14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·July 17, 2015
Logical Constrained Trial Liner 40/60-70mm
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215073022·
MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CYNOSURE CELLULAZE LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·February 26, 2016
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·June 14, 2022
LAPAROSCOPE, REPROCESSED
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code NLM·October 6, 2014
ATTAIN OTW
FDA Adverse Event
Injury
·MPRI·Product code LWP·June 7, 2013
TERUMO TCM II COOLING AND HEATING SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DWC·June 27, 2011
WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·February 22, 2016
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024