13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY
FDA 510(k)
FDA Class 2
·Hematology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496040293·MISS RELAX MICRO RETE 70 SHEER, SIZE L, AVORIO,...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319735268·Bone File 7" (17.5cm), double end, #12CA, bell ...
NA
FDA UDI
Exactech, Inc.·10885862603395·WINDOWED DELTOID RETRACTOR
OSTEONICS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 14, 2026
BIOLOX DELTA CERAMIC FEMORAL HEAD
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code KXA·April 3, 2013
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·May 7, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 5, 2011
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 2020
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013