46 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.

PRODIGY DIABETES MANAGEMENT SOFTWARE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

WIRE END CUTTER

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896051522·WIRE SIDE CUTTER TUNGSTEN CARBIDE BLADES

PMT CORPORATION - STEREOTACTIC

FDA UDI
PMT CORPORATION·00650551038832·RULER, FOR 2.1MM DRILL DRIVER

Orthopaedic Surgical Instruments

FDA UDI
CITIEFFE SRL·08056711921310·

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0131150·Rocker, Hinged Locking

ACTIS ADJUSTABLE CONSTRICTION LOOP

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

XVI R4.5

FDA 510(k)
FDA Class 2 ·Radiology

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 17, 2023

T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 16, 2020

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 30, 2025

RESTORE SENSOR

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 9, 2013

ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code NJE·September 19, 2014

ENDOPATH* REUSABLE ENDOSCOPIC NEEDLE HOLDER

FDA Adverse Event
Malfunction ·ETHICON·Product code GDF·May 25, 2011

NC TREK CORONARY DILATATION CATHETER

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code LOX·December 16, 2022

TREK¿

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·May 27, 2025

I-STAT TROPONIN (CTNI) CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code MMI·February 8, 2023

TREK¿

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026

OT ULTRA2 METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 15, 2018

UNKNOWN OXFORD TIBIAL COMPONENT

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code NRA·August 20, 2025

UNKNOWN OXFORD TIBIAL COMPONENT

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code NRA·August 21, 2025