13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS
FDA 510(k)
FDA Class 2
·Physical Medicine
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
Tiger Supply Inc.
FDA UDI
TIGER SUPPLY, INC.·D82360817201·VPS Putty Regular Set 300ml Base Jar & 300ml Ca...
RAPORT™ KIT
FDA UDI
LSI Solutions, Inc.·00850012846475·RAPORT™ KIT RP-100™
PMMA disc
FDA UDI
Dentsply International Inc.·D00180817200·
Centaur Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215126681·
SYNTHES SACRAL BAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INSERTER-LARGE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·April 29, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 11, 2011
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·July 18, 2008
CANNULA & CATHETER
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DWF·April 22, 2025
Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016