64 results · 28ms · Sources: EU EUDAMED, US FDA

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HUMAN SERUM ALBUMIN (HSA)

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Essential Kit

FDA UDI
MEDIVATORS INC.·40677964008601·Essential Kit includes Suction Tubing, DEFENDO ...

DTS-3000

FDA UDI
DAESUNG MAREF CO.,LTD.·08809315676236·Gray hose 1ea

Thermoflect

FDA UDI
Encompass Group, L.L.C.·00612899004214·THERMOFLECT PEDS GWN KIT 25 EA ...

Mariner MIS

FDA UDI
Seaspine Orthopedics Corporation·10889981255756·Stylet Shuttle, 40mm

INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

CLINI-DENT

FDA 510(k)
FDA Class 1 ·Dental

0008020776-2025-000940

FDA Adverse Event
Injury ·ANTHOGYR SAS·Product code DZE·September 25, 2025

APTIMA HIV-1 QUANT DX ASSAY

FDA Adverse Event
Injury ·HOLOGIC, INC.·Product code MZF·July 16, 2025

8800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 27, 2013

UNKNOWN ZIMMER MIS TIBIAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·February 18, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 12, 2014

TEMPUS PRO, PRINTER

FDA Adverse Event
Malfunction ·REMOTE DIAGNOSTIC TECHNOLOGIES LTD.·Product code MHX·December 30, 2025

ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This device is intended to be used with Anspach Systems

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·July 2, 2014

INTELLIS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 23, 2019

LUMIRADX SARS-COV-2 AG TEST STRIP KIT

FDA Adverse Event
Malfunction ·LUMIRADX UK LTD·Product code QKP·January 25, 2023

LUMIRADX SARS-COV-2 AG TEST STRIP KIT

FDA Adverse Event
Malfunction ·LUMIRADX UK LTD·Product code QKP·January 17, 2023

LUMIRADX SARS-COV-2 AG TEST STRIP KIT

FDA Adverse Event
Malfunction ·LUMIRADX UK LTD.·Product code QKP·September 30, 2022

LUMIRADX SARS-COV-2 AG TEST STRIP KIT

FDA Adverse Event
Malfunction ·LUMIRADX UK LTD.·Product code QKP·September 30, 2022

LUMIRADX SARS-COV-2 AG TEST STRIP KIT

FDA Adverse Event
Malfunction ·LUMIRADX UK LTD·Product code QKP·September 20, 2022