BEUDAMED
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    NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5821109210·FORCEPS, DRESSING, DENTAL

    Copper Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989028676·COPPER NiTi 35 BAF 17x17 LOSM PK/10

    TraXis®

    FDA UDI
    ZIMMER SPINE, INC.·00889024332973·

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306811692·Deaver Blade Small 1 x 3.5"

    TraXis®

    FDA UDI
    ZIMMER SPINE, INC.·00889024332850·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·10884450453855·

    ADVANTAGE MARIJUANA (THC) HOME DRUG TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ADMIRAL XTREME PTA BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 8, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 8, 2014

    GEMSTR 7 THPY ALT ST

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·May 3, 2011

    UNK - SCREWS: LOCKING: CALCANEAL

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HWC·July 29, 2024

    cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas¿¿ PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas¿¿ PCR Female Swab Kit, cobas¿¿ PCR Urine kit, and cobas¿¿ PCR media 100 T kit. -The cobas¿¿ PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas¿¿ CT/NG Test. - The cobas¿¿ PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas¿¿ CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. - In some countries (e.g., UK), the sample collection kit is provided as self-collection for home / personal use, which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. - The cobas¿¿ PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas¿¿ CT/NG Test.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·March 5, 2014

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024