34 results · 21ms · Sources: EU EUDAMED, US FDA

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SIGNATURE PLANNER, SIGNATURE GUIDES

FDA 510(k)
FDA Class 2 ·Orthopedic

HairCheck-DT (THC)

FDA UDI
Quest Diagnostics·00868586000247·HairCheck-DT (THC) is an ELISA test kit used fo...

HHM

FDA UDI
Oticon A/S·05707131268945·H160, DESIGNRITE 10 WL PLI HHM

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690127871·Modular Knee Stem Pilot 25mm x 75mm

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319720745·Gemini-Mixter Forceps 8" (20.3cm), delicate, fu...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197052221·Halsted-Mosquito Hemostatic Forceps 12.5 c...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197052245·Halsted-Mosquito Hemostatic Forceps 1x2 te...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197052252·Halsted-Mosquito Hemostatic Forceps 1x2 te...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197382571·Halsted-Mosquito Hemostatic Forceps 14.0 c...

VLOC9ABSORBABLE WOUND CLOSURE DEVICE

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

QUEST DIAGNOSTICS HAIRCHECK-DT (THC)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·August 8, 2002

ENDURANT

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·May 31, 2013

SYNCHRON CX5 DELTA CLINICAL SYSTEM (C13)

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 27, 2011

8010042-2008-00082

FDA Adverse Event
Malfunction ·Product code CBK·June 19, 2008

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

UNKNOWN VLOC PRODUCT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

UNKNOWN VLOC PRODUCT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

UNKNOWN VLOC PRODUCT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015