121 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AXERA ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
JOBST forMen Casual
FDA UDI
BSN MEDICAL, INC.·00035664131104·FOR MEN CASUAL 15-20 MM HG KNEE HIGH CLOSED TOE...
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493780·
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642104134·Rod Curved 5.5 x 110mm
n/a
FDA UDI
Ortho Development Corporation·00822409076468·Trial Head 26mm + 5
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00846795001620·
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0131100·Assembly, Rod Inserter, Fixed UNID
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0131100·Rocker, One Piece
ANISEIKONIA INSPECTOR
FDA 510(k)
FDA Class 1
·Ophthalmic
MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981037741·31x24 10mm Spin Plate. The Vu a-POD interverteb...
Statcorp Medical
FDA UDI
Statcorp Medical·10841522104442·BP CUFF,TL NYLON,1T,SMALL ADULT,18-26CM,HP,EA
EXPRESS LD ILIAC / BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code NIO·January 8, 2026
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07310K0131100·Rod Inserter, Fixed, 90 Degree, MIS
EXPRESS LD ILIAC / BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code NIO·August 14, 2025
IdentiTi
FDA UDI
ALPHATEC SPINE, INC.·00190376317182·LIF Rasping Distractor, Straight, 6 x 22 mm
MDT Diamond Coated Dental Burs -Sterile
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·67291046158717·FG Rotary diamond instrument for dental applica...
MDT Diamond Coated Dental Burs
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·57291046317957·Rotary diamond instrument for dental application
IdentiTi
FDA UDI
ALPHATEC SPINE, INC.·00190376317212·LIF Rasping Distractor, Straight, 8 x 18 mm
MDT Diamond Coated Dental Burs
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·47291046347988·Rotary diamond instrument for dental application