21 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ALANINE AMINOTRANSFERASE (ALT) TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SICace® Implant
FDA UDI
SIC invent AG·ESIC9351801·SICace Screw Implant Ø 5.0 mm / 13.0 mm incl. C...
Ophthalmic Hook
FDA UDI
KATENA PRODUCTS, INC.·00841668103814·SINSKEY LENS HOOK STRAIGHT
PLIF Allograft
FDA UDI
Seaspine Orthopedics Corporation·10889981090630·Vessel Retractor Post
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955939365·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955937026·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955938191·Percutaneous Transluminal Angioplasty Balloon C...
BIOPSY CUP FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OPIATE EIA ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 21, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·February 3, 2014
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·November 24, 2010
DIAH SEG LOCK SCREW SET
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWT·January 5, 2018
OSS AXLE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·January 19, 2018
OSS REINFORCED YOKE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·January 19, 2018
Presource PBDS, Shoulder Arthroscopy, Kit, Circulator
FDA Enforcement
Class I
·Terminated·Cardinal Health, Medical Products & Services·May 15, 2013
ONCOLOGY SALVAGE SYSTEM - POLY TIBIAL BUSHING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·March 31, 2017
ONCOLOGY SALVAGE SYSTEM - POLY FEMORAL BUSHINGS 2PK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·March 31, 2017
ONCOLOGY SALVAGE SYSTEM - TIBIAL POLY BEARING 16MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·March 31, 2017
OSS ELLIPTICAL DIAPHYSEAL SEGMENT SCREWS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KRO·December 21, 2017