BEUDAMED
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    Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consists of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·December 27, 2017

    Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consists of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code NDP·November 15, 2017

    Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·September 20, 2017

    GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code LXH·April 13, 2022

    Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code LXH·June 26, 2017

    GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

    FDA Enforcement
    Class II ·Terminated·Medacta Usa Inc·June 15, 2022

    GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010

    FDA Recall
    Terminated ·GE Healthcare Integrated IT Solutions·Product code LLZ·December 28, 2007

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

    GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery

    FDA Recall
    Terminated ·Medacta Usa·Product code KRO·April 17, 2015

    Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code KRO·May 19, 2017

    GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery

    FDA Enforcement
    Class II ·Terminated·Medacta Usa·November 25, 2015

    Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Medacta Usa Inc·July 12, 2017

    The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code JWH·October 24, 2017

    ACCESS TRAY/Product SKU's (Codes) ASK-03000-CHUQ, ASK-03000-CHUQ1, ASK-04001-GFH, ASK-04001-SUH and ASK-04001-UHC. Access tray for epidural anesthesia kit

    FDA Recall
    Terminated ·Arrow International Inc·Product code CAZ·October 29, 2010

    GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.

    FDA Recall
    Terminated ·Medacta Usa·Product code HSB·September 22, 2014

    The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF

    FDA Enforcement
    Class II ·Terminated·Medacta Usa Inc·December 27, 2017

    GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.

    FDA Enforcement
    Class II ·Terminated·Medacta Usa·November 19, 2014

    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)

    FDA Recall
    Terminated ·GSK Consumer Healthcare·Product code N/A·April 25, 2016

    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)

    FDA Enforcement
    Class III ·Terminated·GSK Consumer Healthcare·July 20, 2016

    Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.

    FDA Recall
    Terminated ·Ivoclar A. G. Fl-9494 Schaan Liechtenstein·Product code EBC·October 7, 2015