915 results
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28ms
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Sources: EU EUDAMED, US FDA
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·TETRAFILCON A HYDROPHILIC CONTACT LENS
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·MINITHEERM
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·MINITHEERM
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·MINITHEERM
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·MINITHEERM
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·MINITHEERM
Lenses, Soft Contact, Daily Wear
FDA Pre-Market Approval
FDA Class 2
·MINITHEERM
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.
FDA Enforcement
Class II
·Terminated·Med-Hot Thermal Imaging, Inc.·May 17, 2017
Kompressor™ Compression Screw System
FDA UDI
Ascension Orthopedics, Inc.·10381780280163·KOMPRESSOR TEMPLATE, X-RAY
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00880304217249·
LIGHT FOOT REST 18001
FDA UDI
Merivaara Oy·06438435180013·Operating table accessory
Proficient™ Posterior Cervical Spine System
FDA UDI
Spine Wave, Inc.·10840642112573·Screw, 3.8 mm x 8 mm
Sklar®
FDA UDI
SKLAR CORPORATION·10649111017803·HALSEY NH SERR TC 5"
BC Reflex Uni
FDA UDI
Laboratoires Bodycad Inc·00688346001358·
Lasso
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734021569·Lasso Polypectomy Snare
Free-Lock®
FDA UDI
Zimmer, Inc.·00889024035324·
BC Reflex Uni
FDA UDI
Laboratoires Bodycad Inc·00688346001204·
BC Reflex Uni
FDA UDI
Laboratoires Bodycad Inc·00688346001334·
FPS
FDA UDI
Tyber Medical, LLC·00810040689024·MTP Targeting Screw Guide, Left
Proficient™ Posterior Cervical Spine System
FDA UDI
Spine Wave, Inc.·10840642117257·Transition Rod, Ti, 4.0 mm x 5.5 mm x 100 mm