21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM
FDA 510(k)
FDA Class 2
·Dental
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564032751·Basin Pack, Neuro, Duke
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973097·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971215·
PEGASUS NASAL CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
INDISCAL DIGITAL MANOMETER
FDA 510(k)
FDA Class 2
·General Hospital
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·June 18, 2024
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 10, 2013
UNKNOWN NEXGEN KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·May 17, 2013
UV-FLASH SOLUTION TRANSFER SET (SHORT) - JAPAN
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·August 15, 2008
SPRINT QUATTRO
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 13, 2011
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 31, 2019
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·May 20, 2009
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 31, 2019
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015