12 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IDS-iSYS Intact PTHN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
THREADED STEINMANN PINS, BAYONET POINT
FDA UDI
Biomet Orthopedics, LLC·00887868016394·
LIC INSTRUMENT PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
BAKRI TAMPONADE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code OQY·December 17, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 23, 2025
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code MMI·August 4, 2017
TRIATHLON PRIM TIB BASEPLATE - CEMENTED
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·July 8, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
ATTAIN OTW
FDA Adverse Event
Malfunction
·MPRI·Product code LWP·October 10, 2014
Allura Xper FD20/20; System Code: 722038;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024