13 results
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7ms
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Sources: EU EUDAMED, US FDA
Pentax Medical Video Processor; Model Number: EPK-i8020c;
FDA Enforcement
Class II
·Ongoing·Pentax of America Inc·August 27, 2025
Kit BD Max ExK TNA 2; Catalog # 442825
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Kit BD Max ExK DNA 1 USA; Catalog # 442817
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Kit BD Max ExK DNA 2 USA; Catalog # 442819
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
FDA Enforcement
Class II
·Terminated·Flower Orthopedics Corporation·October 13, 2021
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c
FDA Enforcement
Class II
·Ongoing·Pentax of America Inc·March 5, 2025
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
BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.
FDA Enforcement
Class II
·Terminated·JK Products & Services, Inc·August 22, 2012
SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.
FDA Enforcement
Class II
·Terminated·JK Products & Services, Inc·September 19, 2012
SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.
FDA Enforcement
Class II
·Terminated·JK Products & Services, Inc·September 24, 2014
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·December 24, 2025