BEUDAMED
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    PuraStat-GI

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NA

    FDA UDI
    MAKO SURGICAL CORP.·00848486031886·LONG ANTLER

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010101822·SMITH & NEPHEW CEM MIX BOWL ...

    BOOT ASSEMBLY

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 22, 2019

    BOOT ASSEMBLY

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·December 2, 2019

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319744345·Single Skin Hook, 4-15/16" (12.5 cm) overall le...

    Dilator, Vascular, Memory 24cm 4.5mm monobloc

    FDA UDI
    Geister Medizintechnik GmbH·04057034046340·Dilator, Vascular, Memory 24cm 4...

    BOOT ASSEMBLY

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·January 10, 2020

    Savant Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C30422100980·PEEK PLIF Spacer, 22 x 10 x 9mm, 8 deg

    Savant Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C31422100980·Titanium PLIF Spacer, 22 x 10 x 9mm, 8 deg

    STERILE DISPOSABLES FOR MER

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODIFICATION TO CAVERMAP SURGICAL AID

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·August 3, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·October 29, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 3, 2013

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 6.5mm x 35mm; f. 6.5mm x 40mm; g. 6.5mm x 45mm; h. 6.5mm x 50mm; i. 6.5mm x 55mm; j. 7.5mm x 35mm; k. 7.5mm x 40mm; l. 7.5mm x 45mm; m. 7.5mm x 50mm; n. 7.5mm x 55mm; o. 8.5mm x 35mm; p. 8.5mm x 40mm; q. 8.5mm x 45mm; r. 8.5mm x 50mm; s.8.5mm x 55mm; t. 9.5mm x 35mm; u. 9.5mm x 40mm; v. 9.5mm x 45mm; w. 9.5mm x 50mm; x. 9.5mm x 55mm; Used in spinal fixation surgery.

    FDA Enforcement
    Class II ·Terminated·Integrity Implants Inc.·December 14, 2022

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    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