17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Gas Insufflator
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ESCAPE CONTROL MODULE
FDA 510(k)
FDA Class 2
·Physical Medicine
TS FIXTURE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
GENESIS TOTAL KNEE SYSTEM
FDA Adverse Event
SMITH & NEPHEW INC. ORTHOPAEDICS DIV.·Product code HSH·June 29, 1998
RESTORE 3.75X13 SELF-TAP +
FDA Adverse Event
Injury
·LIFECORE BIOMEDICAL, INC.·Product code DZE·May 11, 1998
PORT-A-CATH
FDA Adverse Event
BARD ACCESS SYSTEMS, INC.·Product code LJT·January 29, 1996
TSRH SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·SOFAMOR DANEK MANUFACTURING·Product code KWP·May 19, 1999
FINN TIBIAL BEARING
FDA Adverse Event
Injury
·BIOMET, INC.·Product code KRO·April 25, 1997
CRYOVALVE
FDA Adverse Event
Injury
·CRYOLIFE, INC.·Product code MIE·October 7, 1998
TSRH SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·SOFAMOR DANEK MANUFACTURING·Product code KWP·May 19, 1999
CLARION
FDA Adverse Event
Other
·ADVANCED BIONICS CORPORATION·Product code MCM·July 10, 1998
WALLSTENT RX BILIARY ENDOPROSTHESIS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code FGE·November 6, 2008
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·August 24, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 5, 2013
PLUS KNEE
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HTG·September 16, 1997
Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025