13 results
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29ms
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Sources: EU EUDAMED, US FDA
SERUM, GLUTAMIC-PYRUVIC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ReLine
FDA UDI
Nuvasive, Inc.·00887517010537·RELINE-C Driver, Final Tighten
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813056547·WIRE NI-TEK TYPE-1 RCS .016/L PK/10
Trimline
FDA UDI
ORMCO CORPORATION·00889989050882·UPPER RIGHT FIRST MOLAR TRIMLINE BAND SIZE 16
LEONE SPA
FDA UDI
LEONE SPA·08033707080305·WIRES BETA MEMORIA STRAIGHT 16
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189787·AK3 Femoral Sizer
Saliva, Artificial
FDA Pre-Market Approval
FDA Unclassified
·SALIVART
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
Lateral Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
CODMAN SURGICAL PATTIE
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF·Product code HBA·May 5, 2014
CAPSURE SP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·August 2, 2010
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024