9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106853·UTRATA MICS CAPSULORRHEXIS FCPS FLT HNDL
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209138395·
BASAL MED. EAGLE(BME) W/EARLE'S SALTS, L-GLUTAMINE
FDA 510(k)
FDA Class 1
·Hematology
FIAX TOXO-M ANTIBODIES TEST KIT
FDA 510(k)
FDA Class 2
·Microbiology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 9, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 3, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 18, 2015
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015