23 results · 22ms · 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.

CIRCUL8 Luxe DVT Prevention Device

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777525·LUMBAMED PLUS FLEX PAD M SILVER V

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526780835·LEVAMED ACTIVE ANKLE SUP SLVR R V

Comprehensive® SRS

FDA UDI
Biomet Orthopedics, LLC·00880304540378·

PMT® Halo Systems

FDA UDI
PMT CORPORATION·00650551112433·HALO, 1203-5 VEST LARGE, ACRYLIC LINER, 1211-1 ...

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0112350·Tap, 7.50mm, Fixed Sleeve

GREENLIGHT XPS LASER SYSTEM

FDA Adverse Event
Injury ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·May 16, 2016

SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500

FDA 510(k)
FDA Class 2 ·Hematology

LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

GREENLIGHT XPS LASER SYSTEM

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·February 13, 2017

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·October 29, 2014

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·August 15, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 8, 2013

GREENLIGHT HPS LASER SYSTEM

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·February 25, 2016

GREENLIGHT XPS LASER SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code GEX·April 6, 2022

TAQPATH COVID-19 COMBO KIT

FDA Adverse Event
Malfunction ·LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)·Product code QJR·July 9, 2021

REFOBACIN REVISION 40 -3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·October 15, 2024

GREENLIGHT XPS LASER SYSTEM

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·August 15, 2017

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025