15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NuFACE® FIX+
FDA 510(k)
FDA Class 2
·Neurology
Anatomic PEEK™ Cervical Fusion System with Nanotechnology
FDA UDI
NANOVIS SPINE, LLC·00814216028129·ANATOMIC PEEK w/ Nano 16 x 14 x 5 x 4.6°
VERTE-STACK® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994305213·IMPLANT 6240564 ANATOMIC 16X14X5MM
VERTE-STACK® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000856991·IMPLANT 6240564 ANATOMIC 16X14X5MM
ANATOMIC PEEK CERVICAL FUSION SYSTEM
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994366474·IMPLANT 4240564 ANATOMIC C 16X14X 5MM
Aria System
FDA 510(k)
FDA Class 2
·Cardiovascular
BN LUMBAR CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·April 4, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 19, 2024
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·November 10, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 9, 2011
5MM EXTRA COARSE DIAMOND BALL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
BD DISCARDIT¿ II SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·January 4, 2019
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025