16 results · 22ms · Sources: EU EUDAMED, US FDA

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IRIS 1.0 System

FDA 510(k)
FDA Class 2 ·Radiology

3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

UV PHOTOTHERAPY

FDA Adverse Event
Injury ·UNK·Product code FTC·January 27, 2021

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 14, 2025

UV PHOTOTHERAPY

FDA Adverse Event
Injury ·XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO.·Product code FTC·November 30, 2022

UV PHOTOTHERAPY

FDA Adverse Event
Injury ·UNK·Product code FTC·January 25, 2021

UV PHOTOTHERAPY LAMP

FDA Adverse Event
Injury ·ANGEL KISS LLC.·Product code FTC·February 3, 2021

UV PHOTOTHERAPY

FDA Adverse Event
Injury ·UNK·Product code FTC·January 26, 2021

UV PHOTOTHERAPY LAMP

FDA Adverse Event
Injury ·UNK·Product code FTC·January 29, 2021

UV PHOTOTHERAPY

FDA Adverse Event
Injury ·ANGEL KISS LLC·Product code FTC·February 2, 2021

UV PHOTOTHERAPY LAMP

FDA Adverse Event
Injury ·ANGEL KISS LLC.·Product code FTC·February 4, 2021

IN TOUCH EU

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 21, 2013

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·July 28, 2011

ACCU-CHEK COMPACT PLUS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·July 22, 2008

OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021