26 results · 23ms · 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.

IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4

FDA 510(k)
FDA Class 2 ·Cardiovascular

Zavation

FDA UDI
Zavation LLC·00842166132504·Ti3Z CIF 13mmx15mmx6mm -9 deg

ZAVATION

FDA UDI
Zavation LLC·00842166104594·CIF 13x15, 9 deg, -06

ID NOW COVID-19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·September 29, 2022

ID NOW COVID-19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·September 29, 2022

ID NOW COVID-19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·September 29, 2022

ID NOW COVID-19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·September 29, 2022

MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254

FDA 510(k)
FDA Class 2 ·Cardiovascular

APEX SPINE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ENDOSKELETON TC INTERBODY SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code LXH·March 11, 2026

TM ANKLE PROLONG TIBIAL INSERT SZ 6 +2

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HSN·August 14, 2018

TM ANKLE TIBIAL INSERT COMPONENT SIZE 4

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code ITW·August 9, 2018

ARROW PICC KIT WITH PLACEMENT WIRE

FDA Adverse Event
Injury ·ARROW INTERNATIONAL, INC,·Product code LJS·October 22, 2008

UNICEL® DXC 800 SYNCHRON® SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 12, 2011

ANIMAS INSULIN INFUSION PUMP

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

HTR-PMI CT77-210906 RIGHT FRONTAL PARIETAL IMPLANT

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code KKY·October 26, 2021

TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018

TRABECULAR METAL TOTAL ANKLE TIBIAL INSERT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018

TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018

Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001

FDA Enforcement
Class I ·Ongoing·Whele LLC DBA Perch·November 30, 2022