BEUDAMED
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    Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.

    FDA Enforcement
    Class II ·Terminated·Lumenis·September 23, 2015

    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

    Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE KIT, Medline Kit SKU UROT1044; 2. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770; 3. IV START KIT, Medline Kit SKU DYNDV2520; 4. ARTERIAL LINE BUNDLE, Medline Kit SKU ART255; 5. ON/OFF TRAY, Medline Kit SKU DYNDC2969; 6. IV START KIT, Medline Kit SKU DYNDV2520; 7. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770; 8. (Centurion) ARTERIAL LINE BUNDLE, Medline Kit SKU ART255; 9. ON/OFF TRAY, Medline Kit SKU DYNDC2969; 10. CVAD DRESSING CHANGE KIT, Medline Kit SKU EBSI1364A.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 6, 2026

    Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·January 12, 2022

    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

    W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000

    FDA Enforcement
    Class II ·Ongoing·W&H DENTALWERK BUERMOOS GMBH·February 28, 2024

    Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·February 9, 2022

    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

    Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length.

    FDA Enforcement
    Class II ·Ongoing·Synthes (USA) Products LLC·May 18, 2022

    DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.

    FDA Enforcement
    Class II ·Terminated·Derma Pen, LLC·September 16, 2015

    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

    IBA Proton Therapy System - PROTEUS 235

    FDA Enforcement
    Class II ·Ongoing·Ion Beam Applications S.A.·March 18, 2026

    IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions

    FDA Enforcement
    Class II ·Ongoing·Ion Beam Applications S.A.·September 18, 2024

    IBA Proton Therapy System - PROTEUS 235 - 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 ·Ongoing·Ion Beam Applications S.A.·June 12, 2024

    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