13 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Opulent TiNbN Coated Knee
FDA 510(k)
FDA Class 2
·Orthopedic
STERIL-PEEL
FDA UDI
AMD Medicom Inc·D830222816·STERIL-PEEL SS POUCH 8" X 16"
Pressure Sentinel®
FDA UDI
Zimmer, Inc.·00889024038936·
Pressure Sentinel®
FDA UDI
Zimmer, Inc.·00889024038943·
W & H LISA STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
AXCESS SOFT TIP WIRE GUIDE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 25, 2011
TPS HANDPIECE CORD
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code EIA·November 4, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 12, 2013
VIDAS BRAHMS PROCALCITONIN 60T
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code PRI·July 12, 2021
VIDAS BRAHMS PROCALCITONIN 60T
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code PRI·July 12, 2021
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018