13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033034·Baltic Denture System BDLoad Sm6 PLSEbm6DFs C4 ...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330040·Vise Grip, Small, 5.5mm
MODIFICATION TO: THERMACOOL IIA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COLTENE AURA COMPOMER RESTORATIVE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 3, 2013
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIM·March 29, 2011
DISP HNDSW PENCIL W/HOLSTER
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 22, 2008
EMBRYO RPLCMNT CATHETER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code MQF·September 24, 2019
Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.
FDA Enforcement
Class II
·Terminated·Advanced Orthogonal Equipment, Incorporated·July 31, 2013
Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use
FDA Enforcement
Class II
·Terminated·Cadence Science, Inc.·November 20, 2019
AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed.
FDA Enforcement
Class II
·Terminated·Primus Medical LLC·November 14, 2012
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024