15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)
FDA 510(k)
FDA Class 2
·Ophthalmic
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125549·PowerChem Neoprene Exam Gloves, Large
Reduction Forceps
FDA UDI
I.T.S. GmbH·09120047303832·Reduction Forceps, for 3.5 mm Screws
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100752·FLIERINGA FIXATION RING 14MM
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383552554·Gutta Percha Points is used to root canal filin...
Life Instruments
FDA UDI
Life Instrument Corporation·M930717140433U0·Bayonet Curette #4 Lat Right UP
Life Instruments
FDA UDI
Life Instrument Corporation·M930717140434U0·Bayonet Curette #4 Lat Left UP
HUIBAO BODY FAT SCALE
FDA 510(k)
FDA Class 2
·Cardiovascular
SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE
FDA 510(k)
FDA Unclassified
·Unknown
VC10 PUMP, 115V
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code HHK·January 2, 2025
INTERJECT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FCG·May 27, 2025
BELT CLIP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 14, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
ORTHOPILOT INFRARED TRANSMITTER
FDA Adverse Event
Injury
·AESCULAP IMPLANT SYSTEMS, INC.·Product code HAW·March 5, 2007
TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.
FDA Enforcement
Class II
·Terminated·Tenex Health Inc·May 14, 2014