24 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Oxygen Concentrator
FDA 510(k)
FDA Class 2
·Anesthesiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113400·IMPLANT KNIFE 4.0MM (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113417·IMPLANT KNIFE 5.2MM (BX/5)
BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY
FDA 510(k)
FDA Class 2
·Neurology
READI-LOAD SYSTEM, MODEL PSS 1820RL
FDA 510(k)
FDA Class 2
·Radiology
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·November 5, 2020
TEARDROP HANDLE, AO COUPLING IMPLANT EXTRACTION SE
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 21, 2012
OPTISENSE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code DTB·January 13, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·August 4, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
ENDURANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·March 11, 2024
VALIANT CAPTIVIA UNK
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 20, 2023
TALENT AAA STENT GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·March 11, 2024
TALENT AAA STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·March 11, 2024
ENDURANT II STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 20, 2023
STRATAFIX SPIRAL PDS PLUS UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·March 11, 2024
HARMONIC ACE 5MM SHEAR
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·March 18, 2024
ENDURANT STENT GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·March 11, 2024
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·August 7, 2023
ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017