17 results
·
19ms
·
Sources: EU EUDAMED, US FDA
COMPLEMENT C3 REAGENT SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526787964·EPICOMED ELBOW SUPPORT SILVER II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257003244·M2 OA LITE BRACE, LT VAR, RT VAL, SM
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209102716·KIT, K9 TACTICAL FIELD w' CHITOGAUZE - DUC
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306809934·Khouri Harvester, 12G x 30cm, Luer
ACUMED
FDA UDI
Acumed LLC·10806378040528·Acutrak 2® Mini Trephine
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015
AIM™SUPRACONDYLAR NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868031403·
AIM™SUPRACONDYLAR NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868031410·
AIM™SUPRACONDYLAR NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868031427·
AIM™SUPRACONDYLAR NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868031434·
KSEA CHARDONNES MORCELLATION KNIFE
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
MEDELA THOPAZ, MODEL 200 0288
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EXPRESS® LD ILIAC / BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIO·May 8, 2014
ALAIR BRONCHIAL THERMOPLASTY CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SAN JOSE·Product code OOY·October 22, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 29, 2007
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015