13 results · 21ms · Sources: EU EUDAMED, US FDA

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Braun Thermoscan PRO 6000 Ear Thermometer

FDA 510(k)
FDA Class 2 ·General Hospital

AGC V2 TOTAL KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304242401·

Logical Reamers Tray (Upper)

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215076429·

31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T

FDA 510(k)
FDA Class 2 ·Radiology

SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS

FDA 510(k)
FDA Class 2 ·Orthopedic

RADIFOCUS GLIDEWIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018

UPHOLD VAGINAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTP·April 1, 2016

UPHOLD VAGINAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTP·April 1, 2016

UPHOLD VAGINAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTP·April 1, 2016

UNICEL® DXC 880I SYNCHRON ® ACCESS CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code JJE·June 8, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011

ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023