11 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PolyDev Soft Contact Lenses
FDA 510(k)
FDA Class 2
·Ophthalmic
E-BASIC SINGLE BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS
FDA 510(k)
FDA Class 2
·Orthopedic
ALINITY C LACTATE DEHYDROGENASE REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code CFJ·November 29, 2021
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KXA·June 14, 2013
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·July 1, 2011
VECTRA GENISYS 2CH COMBO
FDA Adverse Event
Injury
·CHATTANOOGA GROUP·Product code IMG·September 23, 2008
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 25, 2026
GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY)
FDA Adverse Event
ABBOTT DIABETES CARE INC.·Product code MDS·September 17, 2021
ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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