24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XSTAT-12, 3-Pack, XSTAT-12, 1-Pack
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XENMATRIX
FDA UDI
Davol Inc.·00801741031397·XenMatrix Surgical Graft, 10 cm x 20 cm (3.9” x...
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304250857·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694032216·2.0mm Cannulated Drill, Fusion, Quick Release
MEGA SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809763500732·Mono Screw Driver
Symmetry Rochester-Pean
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482040256·Symmetry® Forceps, Rochester-Pean Hemostatic, S...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16720031610200·
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 20, 2017
OsteoMed
FDA UDI
OSTEOMED LLC·00845694068345·HPS 2.0 Fusion 2mm Drill Quick Release Sterile ...
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ATRICURE DISSECTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·June 17, 2011
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·October 10, 2014
BELLAFILL DERMAL FILLER
FDA Adverse Event
Injury
·SUNEVA MEDICAL, INC.·Product code LMH·January 6, 2017
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·September 19, 2018
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·March 8, 2021
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·January 11, 2018
GRACE MEDICAL, INC. NOTCHED TITANIUM BUCKET HANDLE
FDA Adverse Event
Injury
·GRACE MEDICAL, INC.·Product code ETB·July 3, 2019
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·October 14, 2019