10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PHILLY INFANT BOLT
FDA 510(k)
FDA Class 2
·Neurology
InSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127029271·Bipolar Head Trial, Size 51mm
NexGen
FDA UDI
Zimmer, Inc.·00889024517882·
NEBULAE I
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
UD-1000 ULTRASONIC A/B SCANNER
FDA 510(k)
FDA Class 2
·Radiology
POWER PRO AMBULANCE COT - OBS
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 20, 2014
GENESIS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODUALTION·Product code LGW·November 2, 2012
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·July 25, 2016
Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021