30 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TLC-2000 Therapeutic Medical Laser System
FDA 510(k)
FDA Class 2
·Physical Medicine
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019
Orthopedic Salvage System (OSS)
FDA UDI
Biomet Orthopedics, LLC·00880304674394·
Apex Connect
FDA UDI
META SYSTEMS CO., LTD.·08809455602027·Apex Connect File Holder B
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321518160·
TALOS®-A
FDA UDI
SpineArt SA·07640375237989·TALOS®-A (HA) PEEK PLANAR, SYMMETRIC IBFD D28 ...
STN PROBE
FDA 510(k)
FDA Class 2
·Radiology
LUMIWAVE 1X4 INFRARED THERAPY DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
ABBOTT
FDA Adverse Event
Malfunction
·ABBOTT CRITICAL CARE·Product code MEA·May 23, 2003
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180529102·MICROSCOPE DP - LIF, RASP, STRAIGHT, SINGLE SID...
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 24, 2025
STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 17, 2021
STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 19, 2022
UNKNOWN COMPRESS SPINDLE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 25, 2019
CARELINK
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DXY·June 7, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 29, 2025
BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 10, 2023