26 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Accent XL
FDA 510(k)
FDA Class 2
·Physical Medicine
X-CORE
FDA UDI
Nuvasive, Inc.·00887517424280·X-CORE 2 Ti Core, Ø16x43-75mm
Young
FDA UDI
YOUNG DENTAL MANUFACTURING I, LLC·00302731600758·Young DPA Vera, Contra Petite Web, Latex Free, ...
SSW CARBIDE TRIMMING AND FINISHING
FDA UDI
Ss White Burs, Inc.·D6901600752·10 BLADE FINISHING CARBIDE SAFE END SE4 - 5 PACK
Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis.
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KPO·October 23, 2015
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889987168371·CORTICAL SHANK, Cannulated, 6.0 X 75
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889981168377·CORTICAL SHANK, Cannulated, 6.0 X 75
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319705377·Halsey Needle Holder 5" (12.5cm), serrated jaws
Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis.
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·November 25, 2015
Medallion®
FDA UDI
Merit Medical Systems, Inc.·00884450024331·
Apelo® / Apelo® MIS
FDA UDI
ATLAS SPINE, INC.·M68111001600750·5.5mm x 75mm MIS Contoured Rod
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
FDA 510(k)
FDA Class 1
·General Hospital
FIBER-METAL POST
FDA 510(k)
FDA Class 1
·Dental
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523129645·7.5 mm Implant Caddy Lid for 6.0 mm Rod
Disposable Automatic Biopsy Gun
FDA UDI
Möller Medical GmbH·04260277177942·
Manual TruCut Biopsy Cannula
FDA UDI
Möller Medical GmbH·04260277173418·
Bone biopsy cannula
FDA UDI
Möller Medical GmbH·04260277173272·
Coaxial needle
FDA UDI
Möller Medical GmbH·04260277171742·
Widex
FDA UDI
Widex A/S·05706069895902·WIDEX EVOKE E-FA (Lime green ) 50, Telecoil, Vo...
TREPHINE ATTACHMENT 7.0MM DIAMETER
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code HWK·July 12, 2017