25 results
·
23ms
·
Sources: EU EUDAMED, US FDA
WUJIN #3 FEMORAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
TruForm
FDA UDI
Rmo, Inc.·00885797099693·MAN MLR BDS ASST 100 SE ASIA
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776363864·Hargis Mandibular Body Retractor
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036006624·
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101090·Distractor, Smooth Paddle, Lordotic, 9mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101090·Distractor, Smooth Paddle, 9mm
NOVABONE-BIOGLASS BONE GRAFT PARTICULATE
FDA 510(k)
FDA Class 2
·Dental
AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code MNH·June 10, 2016
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 13, 2025
MIDAS REX PNEUMATIDC MOTOR
FDA Adverse Event
Injury
·MEDTRONIC POWERED SURGICAL SOLUTIONS·Product code HBB·September 29, 2010
MIDAS REX PNEUMATIC MOTOR
FDA Adverse Event
Injury
·MEDTRONIC POWERED SURGICAL SOLUTIONS·Product code HBB·September 29, 2010
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·March 19, 2013
SPACELABS MEDICAL PATIENT MONITOR
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE·Product code MHX·February 11, 2011
PRECISION XTRA/OPTIUM
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·March 10, 2008
ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LLC - ALCON PRECISION DEVICE·Product code HMX·February 23, 2023
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·H10·Product code KWP·April 4, 2013
UNKNOWN ANKLE TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code HSN·December 17, 2019
UNKNOWN ANKLE TALAR
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code HSN·December 17, 2019
UNKNOWN ANKLE TIBIAL TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code HSN·December 17, 2019