BEUDAMED
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    TRANS1 AXIALIF PLUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673204·LEVAMED STABILI-TRI ANKLE SUP BLU R IV

    JOBST Bella Strong

    FDA UDI
    BSN MEDICAL, INC.·00035664009786·BELLA STRONG 20-30 MM HG ARMSLEEVE DOT BAND SIZ...

    MACROPORENS CRANILOC

    FDA 510(k)
    FDA Class 2 ·Neurology

    CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 30, 2013

    STELLARIS 25G POST VITRECTOMY PACK W WF

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQC·August 27, 2014

    RASCAL

    FDA Adverse Event
    Malfunction ·ELECTRIC MOBILITY CORP.·Product code INI·May 16, 2011

    Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 10-2334, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code FMF·May 19, 2011

    CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled products of Cavicide: Backscratchers Cavicide, part number: 13-4800. MaxiSpray Plus, part numbers: 13-7400 and 13-7405. pdCARE Surface Disinfectant, part numbers: 13-7525 and 13-7500. Z3 Surface Disinfectant, part number: 13-7900. CaviCide is a multi-purpose disinfectant/decontaminant cleaner for use on hard, non-porous inanimate surfaces. CaviCide is a bactericidal, virucidal, fungicidal, and tuberulocidal which is available in a ready-to-use, liquid form typically contained in 1 gallon bottles, 2.5 gallon bottles, 25 oz. spray bottles, or 55 gallon drums (depending on the item number). CaviCide may also be branded as a private label (see (1)(vi) below for names and Table 1 above for additional details). The product may be used (1) for precleaning non-instrument surfaces prior to disinfection; (2) for precleaning instruments prior to disinfection; (3) as a virucide on non-instrument surfaces; (4) as a disinfectant on non-instrument surfaces; (5) as a virucide on precleaned non-critical medical devices, instruments and implements; and (6) as a disinfectant on precleaned non-critical medical devices, instruments, and instruments. It is useful in health care settings such as hospitals, emergency medical settings, surgical centers, isolation areas, neonatal units, patient care areas, ophthalmic and optometric facilities, dental offices, dental operatories, animal care facilities, salon settings, emergency vehicles, schools, health club facilities, kitchens, bathrooms, prisons, morgues, and other critical care areas.

    FDA Enforcement
    Class II ·Terminated·Metrex Research, LLC.·September 5, 2012

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025