29 results · 25ms · 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.

AVA (Augmented Vascular Analysis)

FDA 510(k)
FDA Class 2 ·Radiology

Dornier Thulio Performance Fiber

FDA UDI
INNOVAQUARTZ LLC·00816959021887·

Dornier MedTech

FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116023448·THULIO LL-R TM 200µM 3M PERF. FIBER 3ST 10X USE

24M - Tampa Electric Co.

FDA UDI
Certified Safety Manufacturing, Inc.·00766588013497·24M Tampa Electric Co.

Puget Sound Energy - 18 Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588014692·Puget Sound Energy - 18 Metal

OES Elite Ureteroscopes and Accessories

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

RESPIEVENTS, VERSION 4.2

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·October 27, 2014

N/A

FDA Adverse Event
Malfunction ·STRYKER SUSTAINABILITY SOLUTIONS·Product code NLQ·August 11, 2011

GYNECARE TVT RETROPUBIC SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·July 2, 2013

ARCHITECT IPTH

FDA Adverse Event
Malfunction ·ABBOTT GERMANY·Product code CEW·March 5, 2014

COBAS® MPX - 96T

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 26, 2025

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 15, 2013

ARCHITECT IPTH

FDA Adverse Event
Malfunction ·ABBOTT GERMANY·Product code CEW·November 6, 2013

PROSTAR XL SUTURE-MEDIATED CLOSURE

FDA Adverse Event
Death ·AV-TEMECULA-CT·Product code MGB·March 25, 2014

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Death ·AV-TEMECULA-CT·Product code MGB·March 25, 2014

PROSTAR XL SUTURE-MEDIATED CLOSURE

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·March 25, 2014

THERASPHERE

FDA Adverse Event
Death ·BIOCOMPATIBLES UK LTD·Product code NAW·June 17, 2016