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Sources: EU EUDAMED, US FDA
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The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix¿ Locking Screw with plates for the Tiblaxis, Uni-CP, Advansys MLP and Advansys DLP compression plate systems. The Drilling Guides are initially supplied to users in kits containing the devices that comprise the Tibiaxis, Uni-CP, Advansys MLP and Advansys DLP systems. Should the Drilling Guides need to be replaced, they can be replenished by the customer placing an order. The replacement is shipped to the customer in sealed plastic bags. Uni-CP" Compression Plate The Uni-CP" Compression Plate is indicated for fixation of bone fractures or for bone reconstruction: - Arthrodesis in foot and ankle surgery - Fracture management in the foot and ankle - Mono or bi-cortical osteotomies in the foot and ankle TIBIAXYS" Plates The Newdeal¿ TIBIAXYS" Plates are indicated For fixation of bone fractures or for bone reconstruction. Examples include Osteotomies and fractures of ankle joint, distal tibia and fibula. The Newdeal¿ TIBIAXYS" Plates must be fixed with the Newdeal Surfix¿ 3.5mm diameter fixation screws and lock-screws. ADVANSYS¿ Mid-Foot Plating System: Dorsal Lisfranc Plate (DLP) and Medical Lisfranc Plate (MLP) The Dorsal Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometatarsal joints The Medial Lisfranc Plates are intended for bone fixation such as: arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus: - Lisfranc arthrodesis - Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint
FDA Enforcement
Class II
·Terminated·Integra Life Sci.·September 26, 2012
Knife, Margin Finishing, Operative
FDA classification
FDA Class 1
·Knife, Margin Finishing, Operative
CR MD4.0 GENERAL PLATE
FDA UDI
AGFA·05414904027516·CR MD4.0 GENERAL PLATE 8X10I.
RETRACT EEZ, INC.
FDA registration
RETRACT EEZ, INC.·1 product·🇺🇸 United States
Retract EEZ®
FDA UDI
Ortho Organizers, Inc.·00190707086701·Retract EEZ® Photo Lip Retractor
EIZ LLIF cage
FDA UDI
EIT Emerging Implant Technologies GmbH·04260557833940·EIT LLIF, H 11mm, 0°, 55/18
Simba Apparel EPZ LTD
FDA registration
Simba Apparel EPZ LTD·4 products·🇰🇪 Kenya
LEG EEZE
FDA 510(k)
FDA Class 1
·Physical Medicine
PAIN-EEZ
FDA 510(k)
FDA Class 2
·Neurology
ZOLL-DENTAL
FDA UDI
Zoll-Dental·00840105207603·CJZ
Vitamin C (Ascorbic Acid)
FDA UDI
DRG Instruments Gesellschaft mit beschränkter Haftung·04048474048889·This colorimetric microtiter plate assay is sui...
Vitamin C (Ascorbic Acid)
FDA UDI
DRG International Inc·00840239048882·This colorimetric microtiter plate assay is sui...
FULLCARE (KENYA) MEDICAL TECHNOLOGY EPZ LIMITED
FDA registration
FULLCARE (KENYA) MEDICAL TECHNOLOGY EPZ LIMITED·5 products·🇰🇪 Kenya
Viant Medical SUZHOU EPZ Co., Ltd
FDA registration
Viant Medical SUZHOU EPZ Co., Ltd·2 products·🇨🇳 China
Ea-Z-y Primer™
FDA UDI
PARKELL, INC.·M595S3880·Ea-Z-y Primer™ - Ceramic Primer
Ea-Z-y Primer®
FDA UDI
PARKELL, INC.·00810000529629·Ea-Z-y Primer® - Ceramic Primer
BREATHE WITH EEZ (NASAL DILATOR)
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
E.Z. LOCK WHEELCHAIR RESTRAINT DEVICE
FDA 510(k)
FDA Class 1
·Physical Medicine
E.Z. TEMEP, TEMPORARY FILLING MATERIAL
FDA 510(k)
FDA Class 2
·Dental
EZ WAY, INC.
FDA registration
EZ WAY, INC.·7 products·🇺🇸 United States