67 results
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9ms
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Sources: EU EUDAMED, US FDA
Dimension Vista Prolactin (PRL) Flex reagent cartridge
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·June 28, 2017
Dimension Vista Digoxin (DIGXN) Flex reagent cartridge
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·June 28, 2017
Dimension Vista Estradiol (E2) Flex reagent cartridge
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·June 28, 2017
Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·June 28, 2017
Dimension Troponin 1 (TNI) Flex reagent cartridge
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·June 28, 2017
Dimension Vista Ferritin (FERR) Flex reagent cartridge
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·June 28, 2017
Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 4, 2018
Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The device is a single use implant intended for implantation with bone cement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·October 26, 2016
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO STERILE NAIL NIPPER FLD SPRG 4.5STER25, Model Number 96-2666A; 5) ECONO STERILE NAIL NIPPER 4 1/2" STERILE 50, Model Number 96-2667; 6) ECONO STERILE NAIL NIPPER BRL SPRG 5.5STER25, Model Number 96-2671A; nail procedures
FDA Enforcement
Class II
·Ongoing·Sklar Instruments·January 22, 2025
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
FDA Enforcement
Class II
·Ongoing·Orthofix Srl·June 25, 2025
TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone fixation device for stabilization and correction during the normal healing process. The purpose of the TL-HEX System is to provide a solution for deformity correction and keeping the bone segments aligned during the healing process. The device may only be applied by a physician, who is fully responsible for the surgical and post-operative procedures of the system and is able to manage possible mechanical and software limitations. Indications for use for adults and all pediatric subgroups except newborns include: post-traumatic joint contracture which has resulted in loss of range of motion, fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction, open and closed fracture fixation, pseudoarthrosis of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, correction of bony of soft tissue defects, joint arthrodesis, infected fractures or non unions.
FDA Enforcement
Class II
·Terminated·Orthofix Srl·June 13, 2018
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
FDA Enforcement
Class II
·Terminated·Orthofix Srl·January 3, 2018
ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019