BEUDAMED
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    DR 800 with DSA, DR 800

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517298553·CoRoent® XL-XW, 12x26x45mm 10°

    36M - M.J. Electric - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588121451·36M - M.J. Electric - Metal

    Mediflex Modular III Basic Laparoscopic Instruments

    FDA UDI
    FLEXBAR MACHINE CORPORATION·00842102103513·Modular 3 Rt Angle Mixter Dissector, Insert onl...

    Mediflex Modular III Basic Laparoscopic Instruments

    FDA UDI
    FLEXBAR MACHINE CORPORATION·00842102103506·Modular 3 Rt Angle Mixter Dissector, Complete I...

    MICROPLEX COIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDFUSION

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FRN·April 27, 2023

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 29, 2014

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·July 8, 2011

    COULTER® LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 8, 2013

    Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number 21-2145-01 only for use with Smiths Medical CADD-Solis ambulatory infusion pumps, Model 2100. These cords were sold as an accessory for these pumps under Manufacturing Number A23.164.098.0A, Electri-Cord part Number PC2000403. Electri-Cord AC Power Cords are accessories for use with the CADD-Solis Ambulatory Infusion Pump. These power cords allow users to run the pump via AC power rather than battery power. The CADD-Solis pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code MEA·January 27, 2010

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw AI-0020 20mm AcuTwist¿ Acutrak Compression Screw AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw AI-0026 26mm AcuTwist¿ Acutrak Compression Screw AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw AI-0030 30mm AcuTwist¿ Acutrak Compression Screw AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw

    FDA Enforcement
    Class II ·Ongoing·Acumed LLC·January 4, 2023