56 results
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15ms
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Sources: EU EUDAMED, US FDA
Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
FDA Enforcement
Class III
·Terminated·Pega Medical Inc.·May 27, 2020
Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·December 23, 2020
HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness Not breathing Without circulation
FDA Enforcement
Class I
·Terminated·Heartsine Technologies, Limited·November 7, 2012
ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 22, 2014
ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 22, 2014
ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 22, 2014
1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient.
FDA Enforcement
Class II
·Terminated·American Medical Systems Innovation Center - Silicon Valley·July 29, 2015
LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
FDA Enforcement
Class II
·Terminated·Ion Beam Applications S.A.·April 30, 2014
Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
FDA Enforcement
Class II
·Terminated·Ion Beam Applications S.A.·May 24, 2017
Proteus 235, Proton Therapy System
FDA Enforcement
Class II
·Terminated·Ion Beam Applications S.A.·April 26, 2017
Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
FDA Enforcement
Class II
·Terminated·Ion Beam Applications S.A.·July 18, 2018
Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
FDA Enforcement
Class II
·Terminated·Ion Beam Applications S.A.·July 25, 2018