32 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Novum IQ Syringe Pump
FDA 510(k)
FDA Class 2
·General Hospital
NOVUM IQ
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2025
InCompass®
FDA UDI
ZIMMER SPINE, INC.·00889024401518·
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551111504·HALO, 1203-5 VEST SMALL, ACRYLIC LINER, 1211-1 ...
Mariner Deformity
FDA UDI
Seaspine Orthopedics Corporation·10889981295189·Iliac Tap, Navigated, 12.5mm
Nex-Link®
FDA UDI
ZIMMER SPINE, INC.·00889024332096·
CORTAC®
FDA UDI
PMT CORPORATION·00650551064503·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 25 CO...
CORTAC®
FDA UDI
PMT CORPORATION·00650551064510·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 25 CO...
NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
FDA 510(k)
FDA Class 1
·Anesthesiology
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
CORTAC®
FDA UDI
PMT CORPORATION·00650551089087·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 25 CO...
CORTAC®
FDA UDI
PMT CORPORATION·00650551089070·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 25 CO...
GOLDLINE DISPOSABLE ROCKER SWITCH ELECTROSURGICAL PENCIL
FDA Adverse Event
Malfunction
·CONMED ELECTROSURGERY·Product code GEI·April 29, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 8, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·October 23, 2008
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 8, 2013
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 30 mm, P/N 7211125, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code HWC·August 21, 2007
Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 20, 2018
Allura Xper FD20/15; System Code: 722058;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026