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

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UCP RAPID DRUG SCREENING TESTS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Logical 20° Hooded Liner

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215095260·

POLYESTER NONABSORBABLE SURGICAL SUTURES, USP

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

REGENECARE WOUND GEL

FDA 510(k)
FDA Unclassified ·Unknown

Widex

FDA UDI
Widex A/S·05706069687132·Widex EVOKE E-IM (Light beige ) 440, Left

Widex

FDA UDI
Widex A/S·05706069687156·Widex EVOKE E-IM (Dark brown ) 440, Left

Widex

FDA UDI
Widex A/S·05706069687149·Widex EVOKE E-IM (Clay brown ) 440, Left

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 3, 2025

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES (DBA ANGIOTECH)·Product code GAW·April 3, 2008

D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR W/ INTEGRATED RESERVOIR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTZ·November 15, 2018

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·February 12, 2013

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAP·September 16, 2008

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·September 23, 2009

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·May 15, 2008

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Injury ·SURGICAL SPECIALITIES CORP·Product code GAW·February 25, 2014

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP (DBA ANGIOTECH)·Product code GAW·October 22, 2009

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·March 11, 2013

HEART START XL

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 5, 2011

ACTIVE FIXATION ENDOCARDIAL LEAD

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025