27 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VITROS XT Chemistry Products ALB-TP Slides
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Bernafon
FDA UDI
Bernafon AG·05711584086032·ZR3 B 105, 2.4G NFM DPB SABE/MSIL ZERENA 3
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690199052·AK3 Congruent Insert Trial Size 3, 16mm
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107705·TRIAL 90-SRK-191316 POLY-MPCS 3X16 RIGHT
LANX SPINAL FIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AAP CANNULATED SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 24, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 21, 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
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MCX·June 26, 2013
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 27, 2011
CAREASSIST
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·September 26, 2008
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 29, 2025
BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code MJC·June 19, 2025
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 27, 2025
COMP NLK SCR 3.5HEX 4.75X25 XT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·July 23, 2020
COMP LK SCR 3.5HEX 4.75X20 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·July 23, 2020
M-VIZION PROXIMAL BODY HANDLE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·March 28, 2024
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·May 28, 2026