20 results
·
23ms
·
Sources: EU EUDAMED, US FDA
OptiVu Shoulder
FDA 510(k)
FDA Class 2
·Neurology
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813053263·NITI ROTARY FILE S20/T04 31MM DARBY
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106327·CASTROVIEJO FORCEPS 0.9MM
INTUITION
FDA UDI
DEPUY (IRELAND)·10603295544555·INTUITION FOR HP PARTIAL FEMORAL FINISHING BLOC...
INTUITION
FDA UDI
DEPUY (IRELAND)·10603295544531·INTUITION FOR HP PARTIAL FEMORAL FINISHING BLOC...
INTUITION
FDA UDI
DEPUY (IRELAND)·10603295544616·INTUITION FOR HP PARTIAL FEMORAL FINISHING BLOC...
INTUITION
FDA UDI
DEPUY (IRELAND)·10603295544593·INTUITION FOR HP PARTIAL FEMORAL FINISHING BLOC...
INTUITION
FDA UDI
DEPUY (IRELAND)·10603295544579·INTUITION FOR HP PARTIAL FEMORAL FINISHING BLOC...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197176989·Watson-Williams Ethmoidal Forceps
for mu...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197450157·Ferris-Smith Nasal Forceps with serrated
jaws w...
devemed
FDA UDI
devemed GmbH·04061644021826·Periodontal Probe # CP11.5B (WHO)
graduated; 3....
INTUITION
FDA UDI
DEPUY (IRELAND)·10603295544517·INTUITION FOR HP PARTIAL FEMORAL FINISHING BLOC...
UCP Stem
FDA 510(k)
FDA Class 2
·Orthopedic
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Reicodent
FDA UDI
devemed GmbH·04061644035113·Periodontal Probe # CP11.5B (WHO)
graduated; 3,...
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·September 17, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014
HS III PROXIMAL SEAL SYSTEM 4.3MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·July 23, 2013
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014