21 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LENSAR Laser System - fs 3D
FDA 510(k)
FDA Class 2
·Ophthalmic
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169631854·CHISEL 2143010 ANGLED BOX CHISEL - 10MM
V. Mueller
FDA UDI
STERIS CORPORATION·10885403279249·V. Mueller DISPOSABLE BIPOLAR FORCEPS
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158213111·UTERINE DILATOR HANK FIG. 9/10 DOUBLE ENDED 4.5...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613018580·Sickle Knife, Adult, 9mm Curved Blade, Sharp, F...
LEONE SPA
FDA UDI
LEONE SPA·08033707011682·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 10
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1430200·Rod Template, 250mm
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HOLTER RECORDER H3+
FDA 510(k)
FDA Class 2
·Cardiovascular
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·June 3, 2013
PLUM A+ DRIVER NEW
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·September 12, 2014
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 23, 2011
VANGUARD INTERLOK FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·May 18, 2018
VANGUARD INTERLOK XP TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·May 18, 2018
Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·February 19, 2014
VANGUARD INTERLOK TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·May 18, 2018
VANGUARD XP MEDIAL TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·May 18, 2018
VANGUARD INTERLOK FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·May 18, 2018
VANGUARD XP LATERAL TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·May 18, 2018
INTIMA II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·October 31, 2018