12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CoRoent
FDA UDI
Nuvasive, Inc.·00887517283405·CoRoent® Large MP, 8x9x23 8°
PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
FDA 510(k)
FDA Class 2
·Immunology
SPAZZ
FDA 510(k)
FDA Class 1
·Physical Medicine
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
S5 CONSOLE FOR 4 PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 1, 2010
BD¿ LUER-LOK SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·March 9, 2018
FOUNDATION KNEE
FDA Adverse Event
ENCORE MEDICAL, L.P.·Product code JWH·April 26, 2013
THERAPY/CPR CABLE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 25, 2014
BENCO PL. 30 GA NEEDLE
FDA Adverse Event
Injury
·S.O.F.I.C. S.A.·Product code DZM·June 26, 2008
Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15302 G14326
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 12, 2020
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018