28 results · 32ms · 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.

Becker External Drainage and Monitoring System

FDA 510(k)
FDA Class 2 ·Neurology

Drill

FDA UDI
Treace Medical Concepts, Inc.·00810111227179·Drill

ACUMED

FDA UDI
Acumed LLC·10806378014185·3.5mm x 28.0mm Locking Cortical Screw

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319742679·Hohmann Retractor 8-3/4" (21.9cm), blade 8mm wide

ACUMED

FDA UDI
Acumed LLC·10806378014192·3.5mm x 28.0mm Locking Cortical Screw

EASI 12 LEAD ALGORITHM

FDA 510(k)
FDA Class 2 ·Cardiovascular

HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2

FDA 510(k)
FDA Class 2 ·General Hospital

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Injury ·TANDEM DIABETES CARE·Product code LZG·February 22, 2017

OPHTHALMIC FEMTOSECOND LASER

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·February 9, 2021

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

RESERVOIR 3ML

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code FRN·September 17, 2014

UNKNOWN DEPUY SUMMIT STEM #5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·July 1, 2013

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·February 16, 2021

UNK RIGIDFIX CROSSPIN

FDA Adverse Event
Injury ·DEPUY MITEK·Product code MAI·August 25, 2016

CATALYS PRECISION LASER SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·February 8, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 19, 2021