46 results · 25ms · Sources: EU EUDAMED, US FDA

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Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System

FDA 510(k)
FDA Class 2 ·Orthopedic

LACE UP

FDA UDI
RIVERPOINT MEDICAL, LLC·00812444026177·SUTURE

Dornier MedTech

FDA UDI
Dornier MedTech GmbH·04049958001741·400 Micron Disposable Diode Laser Lightguide, 0...

FAC-4 - Duke Power Cabinet

FDA UDI
Certified Safety Manufacturing, Inc.·00766588015293·FAC-4 - Duke Power Cabinet

OsteoMed

FDA UDI
OSTEOMED LLC·00845694041034·Plate Bending Forceps, Large

ABP-2000 G-3

FDA 510(k)
FDA Class 2 ·Cardiovascular

GEIGER NEEDLE ADAPTER, MODEL 406

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

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 27, 2025

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE LTD·Product code FRN·October 20, 2008

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 11, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 2, 2013

NEEDLE 18GA 2IN

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·July 13, 2021

INJECTOR LOCKING N40-O

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 15, 2021

POLY-L-LACTIC ACID (POLY-L-LACTIC ACID)

FDA Adverse Event
Injury ·SANOFIAVENTIS U.S. LLC·Product code LMH·April 2, 2010

ACRYSOF

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·December 17, 2010

BD PHASEAL OPTIMA INJECTOR (N40-O)

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 14, 2021

SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098

FDA Enforcement
Class II ·Ongoing·PATH·December 6, 2023

KINETRA

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·October 25, 2010

GELFOAM

FDA Adverse Event
Malfunction ·PFIZER, INC. (DEVICE)·Product code LMF·May 6, 2019