12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROTOOLS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295253662·LARGE BLADE STANDARD
B & L OPHTHALMIC INSTRUMENT STAND
FDA 510(k)
FDA Class 1
·Ophthalmic
CD TELEMETRY SYSTEMS
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCESSORIES
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 6, 2013
Z-STENT DUA ANTI-REFLUX VALVE ESOPHAGEAL STENT
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code ESW·February 11, 2011
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014
ACIST
FDA Adverse Event
Malfunction
·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·April 20, 2007
INDEFLATOR
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code MAV·February 27, 2024
INDEFLATOR
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code MAV·March 21, 2024
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024