22 results · 35ms · 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.

QUEST TUMOR MARKER CONTROL, MODEL 955

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496042815·ARM CARE CCL.1, SIZE M, NERO, GRADUATED COMPRES...

GOLD CORE HF PRE SOLDER

FDA 510(k)
FDA Class 2 ·Dental

SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE

FDA 510(k)
FDA Class 1 ·General Hospital

Octane Straight

FDA UDI
Choice Spine, LP·10885862236074·

Octane Straight PC

FDA UDI
Choice Spine, LP·10885862278487·

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 21, 2025

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code NKB·April 9, 2013

HEARTSTART MRX - EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·March 30, 2011

FINELINE II EZ

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

M-LNCS Y-I

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·August 12, 2017

UNKNOWN SHOULDER LOCKING SCREW

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code PHX·August 1, 2022

UNK SHOULDER GLENOSPHERE DELTA XTEND

FDA Adverse Event
Injury ·DEPUY IRELAND - 9616671·Product code HSD·August 1, 2022

UNKNOWN SHOULDER METAGLENE

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code HSD·August 1, 2022

UNK SHOULDER HUMERAL CUP DELTA XTEND

FDA Adverse Event
Injury ·DEPUY IRELAND - 9616671·Product code HSD·August 1, 2022

UNKNOWN SHOULDER LOCKING SCREW

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code PHX·August 1, 2022

UNK SHOULDER HUMERAL STEM DELTA XTEND

FDA Adverse Event
Injury ·DEPUY IRELAND - 9616671·Product code HSD·August 1, 2022

UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND

FDA Adverse Event
Injury ·DEPUY IRELAND - 9616671·Product code KWS·August 1, 2022

SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

FDA Enforcement
Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019