11 results
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27ms
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Sources: EU EUDAMED, US FDA
RICA OR SMIC SURGICAL INSTRUMENTS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209111718·KIT, TCCC IFAK SKILLS RE-SUPPLY - ALL COMBATANT
SIGNA 3.0T MR750 SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
WORTHINGTON FLOZYME* CPK (340NM)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NA
FDA UDI
Zimmer, Inc.·00889024023598·
TENDRIL ST
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·May 8, 2014
M2A-MAGNUM 42-50 TAPER INSERT STD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 21, 2007
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
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024
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