16 results
·
22ms
·
Sources: EU EUDAMED, US FDA
CIRCUMAURAL ADHESIVE REPLACEMENT
FDA 510(k)
FDA Class 2
·Neurology
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169601628·SPACER 2111555 OLIF25 20MM 6 DEG 16X55
A Series
FDA UDI
Respironics, Inc.·00606959021563·A Series System One Heated Tube Humidifier, Int...
OptumSI Implant System
FDA UDI
SI Solutions, LLC·00850057247220·Sacroiliac Joint Fusion Implant, 11.5mm x 55mm
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213033863·Coupling Treatment Tube for 5F Flexibles (23)
BD¿ SYRINGE ONLY SLIP TIP, NON-STERILE, BULK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 22, 2018
ARCOMXL ACTIVE ARTICULATION
FDA 510(k)
FDA Class 2
·Orthopedic
CO2 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 Ø11X380MM X 125°
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS-KIEL·Product code HSB·April 12, 2013
FOX PLUS PTA CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LIT·May 14, 2013
UNKNOWN DEPUY POLY CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 13, 2011
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LGW·August 13, 2008
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·March 3, 2025
Plum XL, list numbers 11555-04-01, 11555-04-03, 11555-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
FDA Recall
Terminated
·Hospira Inc·Product code FRN·August 11, 2009
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025