14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
RIANEN ESTRIOL RADIOIMMUNOASSAY KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78403011·Micro Sprint Bracket Roth .022" max. 3 right
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78403010051·Micro Sprint Bracket Roth .022" max. 3 right
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78403010101·Micro Sprint Bracket Roth .022" max. 3 right
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78403011001·Micro Sprint Bracket Roth .022" max. 3 right
GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MammoScreen® (3)
FDA 510(k)
FDA Class 2
·Radiology
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·June 5, 2025
UNKNOWN ORTHOPEDIATRICS SCREW
FDA Adverse Event
Malfunction
·ORTHOPEDIATRICS, INC·Product code HWC·February 23, 2020
UNKNOWN ORTHOPEDIATRICS SCREW
FDA Adverse Event
Malfunction
·ORTHOPEDIATRICS, INC·Product code HWC·February 23, 2020
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 30, 2014
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code DTB·November 20, 2012
PATIENT ROOM WALL SAVER RECL
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIVISION·Product code FRK·September 10, 2010
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