14 results · 22ms · Sources: EU EUDAMED, US FDA

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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