60 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.

FASTX STERNAL INTRAOSSEOUS DEVICE

FDA 510(k)
FDA Class 2 ·General Hospital

MaXcess

FDA UDI
Nuvasive, Inc.·00887517174376·MAS Micro-Decomp Curette, Ang Med

SONTEC OLSEN-HEGAR NEEDLE HOLDER

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896046177·SONTEC OLSEN-HEGAR NEEDLE HOLDER SERRATED TIP

Ormco

FDA UDI
ORMCO CORPORATION·00889989026948·SS BROAD ARCH ROUND140 UP LGE PK/20

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450172117·

PerformancePlus™

FDA UDI
GRAPHIC CONTROLS ACQUISITION CORP·70813150020625·

SENSATION -VACUUM ASSIST DEVICES

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ARTHREX UNIVERS 30 SHOULDER PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 8, 2022

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 27, 2021

T:SLIM G4 SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OYC·October 9, 2020

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 28, 2025

OT VERIO SYNC METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 11, 2015

TRUEMETRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·March 22, 2017

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 11, 2011

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 11, 2011

CEMENT, BONE, VERTEBROPLASTY

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code NDN·May 8, 2013

HI PWR DISPOSBL GRNDING PAD

FDA Adverse Event
Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code ODR·August 5, 2008

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 24, 2011

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 30, 2011