34 results · 26ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Wireless Pain Relieve Device

FDA 510(k)
FDA Class 2 ·Neurology

DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code PQF·April 29, 2018

DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code PQF·April 29, 2018

DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code PQF·April 28, 2018

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100331601·IN-OVATION® C Roncone 018 UL/ 3-3 CS HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100331101·IN-OVATION® C Base Rx 018 UL/3-3 CS HK

VIDAS® HCG

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code JHI·December 13, 2017

GORE® EXCLUDER® AAA ENDOPROSTHESIS

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code MIH·August 25, 2016

SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

SENSITITRE AIM (TM)

FDA 510(k)
FDA Class 2 ·Microbiology

X-STOP IPD SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SPINE LLC.·Product code NQO·September 3, 2010

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·October 15, 2014

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·July 27, 2011

PINNACLE PELVIC FLOOR REPAIR KITS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300

FDA Enforcement
Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV2 RCP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

OPTILENE 7/0 (0,5) 60CM 2XDRC8 CV2 RCP

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300

FDA Enforcement
Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018

GORE® TAG® THORACIC ENDOPROSTHESIS

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code MIH·June 19, 2017

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301

FDA Enforcement
Class II ·Completed·Bard Peripheral Vascular Inc·May 16, 2018