12 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Exactech Equinoxe Humeral Augmented Trays
FDA 510(k)
FDA Class 2
·Orthopedic
Orthos
FDA UDI
ORMCO CORPORATION·00889989030099·ORTHOS CM SST ARCH 18 DIA LOSM PK10
DISPOSABLE EYE BLADES
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896019676·DISPOSABLE EYE BLADES CASE #69
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551811·IN-OVATION® mini EURO 018/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551821·IN-OVATION® mini EURO 018/5-5 CBC HK
TX1 TISSUE REMOVAL SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE
FDA 510(k)
FDA Class 3
·Cardiovascular
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 21, 2023
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·July 20, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·June 26, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 22, 2014
TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 27, 2012