11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
LULMITEX NEONATAL TRANSILLUMINATOR
FDA 510(k)
FDA Class 1
·Ophthalmic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471144330·PASSING PIN - DRILL TIP 2.4mm DIA x 385mm
TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)
FDA 510(k)
FDA Class 2
·Cardiovascular
Yxoss CBR®
FDA 510(k)
FDA Class 2
·Dental
SECUR-FIT MAX
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LZO·January 7, 2013
ARTHROCARE SPINEWAND
FDA Adverse Event
Other
·ARTHROCARE CORP.·Product code HRX·October 6, 2010
INTERSTIM
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code EZW·July 3, 2014
3.9MM KNOTLESS CORKSCREW, PEEK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·October 11, 2019
3.9MM KNOTLESS CORKSCREW, PEEK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·October 11, 2019
FIBERTAK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MBI·October 11, 2019
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021