19 results · 29ms · 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.

PASTES, RESTORATIVE & TINTED, DEBTAL

FDA 510(k)
FDA Class 2 ·Dental

POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE)

FDA 510(k)
FDA Class 1 ·General Hospital

GM85

FDA 510(k)
FDA Class 2 ·Radiology

MALLINCKRODT

FDA Adverse Event
Malfunction ·MALLINCKRODT MEDICAL·Product code BTS·May 23, 2018

MALLINCKRODT

FDA Adverse Event
Malfunction ·MALLINCKRODT MEDICAL·Product code BTS·April 27, 2018

MALLINCKRODT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTS·June 21, 2011

MALLINKCRODT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY TYCHOHEALTHCARE·Product code BTS·September 30, 2010

MALLINKCRODT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTS·September 30, 2010

MALLINKCRODT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTS·September 30, 2010

MALLINCKRODT

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code CBI·June 16, 2011

MALLINCKRODT

FDA Adverse Event
Malfunction ·MALLINCKRODT MEDICAL·Product code BTS·October 9, 2017

MALLINCKRODT

FDA Adverse Event
Malfunction ·MALLINCKRODT MEDICAL·Product code BTS·November 13, 2017

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 24, 2014

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 3, 2012

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 5, 2008

MALLINCKRODT

FDA Adverse Event
Malfunction ·MALLINCKRODT MEDICAL·Product code BTS·November 19, 2018

MALLINCKRODT

FDA Adverse Event
Malfunction ·MALLINCKRODT MEDICAL·Product code BTS·July 14, 2017

MALLINCKRODT

FDA Adverse Event
Malfunction ·MALLINCKRODT MEDICAL·Product code BTS·April 2, 2018

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