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Articles
1-89 out of 89 article(s)
| Title |
Author |
Type |
Date |
Words |
| Stull, Stull & Brody Announces Investigation on Behalf of Shareholders of Aspect Medical Systems, Inc. |
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Oct 5, 2009 |
340 |
| Levi & Korsinsky, LLP Investigates Possible Breach of Fiduciary Duty by the Board of Aspect Medical Systems, Inc. - ASPM. |
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Sep 30, 2009 |
218 |
| Law Offices of Howard G. Smith Announces Investigation On Behalf of Shareholders of Aspect Medical Systems, Inc. |
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Sep 29, 2009 |
221 |
| Fresenius Medical Care Announces Completion of Government Investigation. |
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May 6, 2009 |
377 |
| Cardima Receives CE Mark Approval for its Surgical Ablation Probe with Stabilization Sheath. |
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Apr 1, 2009 |
753 |
| ArthroCare Announces Review of Insurance Billing Practices; CEO Departure and Management Changes; Investigations by SEC and US Attorney Offices in Florida and North Carolina. |
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Feb 18, 2009 |
1491 |
| NeuroMetrix Resolves Investigation into Past Sales and Marketing Practices. |
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Feb 9, 2009 |
519 |
| Advertising Standards tipped off by optom over Chinese eye massager. |
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Jan 30, 2009 |
352 |
| The quest to ensure transparency in physician relationships continues. |
Langdon, Mark |
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May 1, 2008 |
1423 |
| Senate scrutinizes physician consultants. |
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Mar 1, 2008 |
875 |
| Orthopedic companies settle DOJ probe, face SEC scrutiny; Medtronic loses a patent suit to Johnson & Johnson, releases new spinal device. |
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Nov 1, 2007 |
729 |
| Biomet Announces Resolution to Government Investigation. |
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Sep 27, 2007 |
613 |
| Federal team arrests 38 for Medicare fraud. |
Schneider, Mary Ellen |
Brief article |
Jul 1, 2007 |
238 |
| Business as usual? |
Delporte, Christopher |
Editorial |
Jul 1, 2007 |
443 |
| Judge rejects some claims of Mosher. |
Madler, Mark R. |
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Dec 4, 2006 |
625 |
| Toshiba's Diagnostic Imaging System Used to Investigate Aircraft Component Reliability. |
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Nov 21, 2006 |
353 |
| Orthometrix hit with 1-item 483 for consent flaws at 3 sites. |
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Oct 1, 2006 |
534 |
| Treatment probe clouds outlook as DaVita gains. |
Darmiento, Laurence |
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Dec 13, 2004 |
1381 |
| Problems at testing firm exceed initial disclosures: directors of diagnostic products includes Nobel Laureate James Watson. |
Darmiento, Laurence |
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Apr 12, 2004 |
1193 |
| Problems at Testing firm exceed initial disclosures. |
Darmiento, Laurence |
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Apr 5, 2004 |
1285 |
| Orthofix International. |
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Brief Article |
Oct 1, 2003 |
90 |
| CardioCommand hit with validation, verification deviations. |
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Sep 1, 2003 |
346 |
| CSF shunt maker must revalidate sterilization, 510(k) commitment cited. |
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Sep 1, 2002 |
551 |
| Pair of medical gas companies not calibrating analyzers properly. |
Witkowski, Wallace |
Brief Article |
Sep 1, 2002 |
231 |
| Device reprocessor lacks cleaning/sterility validation, 510(k), FDA says. |
Witkowski, Wallace |
Brief Article |
Aug 1, 2002 |
202 |
| Hands-on work lacks validation for Italian firm. |
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Brief Article |
Feb 1, 2002 |
533 |
| Warning letter for device manufacturer cites design control SOP. |
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Brief Article |
Feb 1, 2002 |
199 |
| Purchase of unvalidated product line brings warning, caution re: family validation. |
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Brief Article |
Jan 1, 2002 |
736 |
| SeQual loses MDR debate over oxygen concentrators. |
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Brief Article |
Nov 1, 2001 |
887 |
| X-ray maker cited for design controls, environmental issues, calibration. |
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Brief Article |
Nov 1, 2001 |
488 |
| Braun's I.V. sets slapped for validation faults. |
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Brief Article |
Nov 1, 2001 |
265 |
| Electrode maker fails to verify correction for 'dull needles'. |
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Brief Article |
Nov 1, 2001 |
174 |
| Plain-Jane GMPs litter 483, warning letter for X-ray firm. |
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Brief Article |
Oct 1, 2001 |
443 |
| Euro device maker dodges 483, but FDA inks warning. |
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Brief Article |
Oct 1, 2001 |
674 |
| Swedish wheelchair maker trips over documentation. |
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Brief Article |
Oct 1, 2001 |
936 |
| Warnings given to medical gas firms for GMP issues, including calibration. |
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Brief Article |
Oct 1, 2001 |
701 |
| Lack of QC, QA cited at hydrotherapy maker. |
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Brief Article |
Oct 1, 2001 |
208 |
| Not documenting validation of design requirements, software draws warning. |
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Brief Article |
Oct 1, 2001 |
450 |
| Warning letter cites problems with PHS custom medical kits. |
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Brief Article |
Sep 1, 2001 |
681 |
| Design control, acceptance testing among firm's shortcomings. |
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Brief Article |
Sep 1, 2001 |
220 |
| Seizures, injunctions up among drug, device firms : No prosecutions, but warnings increase. |
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Brief Article |
Sep 1, 2001 |
820 |
| Residue sampling, water system design, trip Baxter. |
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Brief Article |
Sep 1, 2001 |
877 |
| Market, GMP/ISO burdens drive J-Lloyd into closure. |
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Brief Article |
Sep 1, 2001 |
747 |
| Catheter firm delineation of design process faulted. |
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Brief Article |
Jul 1, 2001 |
279 |
| CAPAs, SOPs trip Prosec; firm didn't reply to 483. |
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Brief Article |
Jul 1, 2001 |
207 |
| Cardiomedics quality audits, design controls spur letter. |
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Brief Article |
May 1, 2001 |
392 |
| EtO validation yields letter to convenience kit maker. |
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Brief Article |
May 1, 2001 |
201 |
| Design validation, CAPAs noted at prosthetics maker. |
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Brief Article |
May 1, 2001 |
567 |
| DEVICES: Annotations, responses to 483s crucial. |
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Brief Article |
May 1, 2001 |
536 |
| Florida firm, FDA volley over proposed corrections. |
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Brief Article |
Apr 1, 2001 |
938 |
| FDA wants justification for validation of product family. |
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Brief Article |
Apr 1, 2001 |
564 |
| Enviromental monitoring, cleaning snares Walsh. |
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Brief Article |
Mar 1, 2001 |
282 |
| Tube maker tangles with FDA over EtO validation. |
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Brief Article |
Mar 1, 2001 |
791 |
| 510(k)s. |
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Brief Article |
Jan 1, 2001 |
69 |
| Electronic Records/Computer-software validation. |
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Brief Article |
Jan 1, 2001 |
102 |
| General Device/Evaluation Documents. |
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Brief Article |
Jan 1, 2001 |
401 |
| Medical Devices - Critical Disposables cited for design control faults. |
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Brief Article |
Oct 1, 2000 |
533 |
| Artificial skin maker's processes, water cited. |
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Brief Article |
Sep 1, 2000 |
188 |
| Contract sterilizer in U.K. hit on process validation. |
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Brief Article |
Sep 1, 2000 |
106 |
| Design, process validation cited at Phoenix Medical. |
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Brief Article |
Sep 1, 2000 |
165 |
| EtO sterilization validation faulted at German firm. |
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Brief Article |
Sep 1, 2000 |
239 |
| Abbott DD's reversal: VAI in '97, $100 million hit in '99. |
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May 1, 2000 |
1307 |
| Israeli firm has 2 MDRs, good GMPs, gets no 483. |
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Brief Article |
Apr 1, 2000 |
583 |
| Small firm lacks CAPAs, MDRs, has no complaints. |
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Brief Article |
Apr 1, 2000 |
694 |
| Medicor nets small EIR, but big FDA headaches. |
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Brief Article |
Jan 1, 2000 |
455 |
| GE-Marquettte software recall yields 483, warning. |
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Dec 1, 1999 |
1094 |
| Mallinckrodt, FDA argue OOS release, complaints. |
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Sep 1, 1999 |
1567 |
| Becton-Dickinson software for lot-testing not validated. |
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Brief Article |
Sep 1, 1999 |
360 |
| Baxter finds plane crash a snap, validation tougher. |
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Aug 1, 1999 |
881 |
| Bird Life, Clarus cited for process validation faults. |
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Brief Article |
Aug 1, 1999 |
323 |
| Packaging cited at Becton, Mercury hit on calibration. |
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Brief Article |
Aug 1, 1999 |
348 |
| Diametrics Medical cited for QS process validation. |
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Brief Article |
Jul 1, 1999 |
265 |
| Packing, sterilization validation yields warning to Sterimed. |
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Brief Article |
Apr 1, 1999 |
318 |
| 'Voluminous' QC data on paper worries FDA. |
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Brief Article |
Apr 1, 1999 |
648 |
| Steris, FDA hash out stability, MDR issues. |
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Apr 1, 1999 |
1147 |
| FDA's clinical investigator surveillance burden shifts as warning letters surge : 'Critical control points' approach ahead. |
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Brief Article |
Mar 1, 1999 |
2109 |
| Complaint triggers audit of prefilled syringe firm. |
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Brief Article |
Mar 1, 1999 |
418 |
| CardioMed receives no warning letter, but no 510(k) clearances, either. |
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Jan 1, 1999 |
987 |
| Unresponsive sterilizer raises hackles at FDA. |
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Brief Article |
Jan 1, 1999 |
919 |
| Two-man operation receives five-item 483. |
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Brief Article |
Jun 1, 1998 |
345 |
| QS rule, design controls are news to small firm. |
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Brief Article |
Jun 1, 1998 |
299 |
| Software firm gets by with no design controls. |
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Brief Article |
Jun 1, 1998 |
193 |
| Design controls a breeze, COMSTAT bothers Luther. |
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Jun 1, 1998 |
800 |
| FDA hits Ortho QA system, asks for third-party audit. |
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Brief Article |
Oct 1, 1997 |
923 |
| Alcon revises SOPs after lens recall, warning letter. |
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Brief Article |
Sep 1, 1997 |
643 |
| INSPECTION LOG. |
|
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Aug 1, 1997 |
899 |
| LifeCell Corp. makes announcement. |
|
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Nov 17, 1995 |
357 |
| Interactive Medical Technologies Ltd. makes announcement. |
|
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Oct 27, 1995 |
187 |
| VISX Responds To FTC Request. |
|
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Oct 17, 1995 |
143 |
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