64 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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