BEUDAMED
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    SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950018666·FORCEP SCHNIDT SLIGHTLY CURVED 7-1/2" 19CM

    CliP Partial Prosthesis Titanium

    FDA UDI
    Heinz Kurz GmbH·EHKM10022741·Ossicular Prosthesis, partial

    GRADIA®

    FDA UDI
    Gc America Inc.·14548161075312·GRADIA® DIRECT Syringes: 1 syringe (2.7 mL) B1

    GRADIA®

    FDA UDI
    Gc America Inc.·D0470022741·GRADIA® DIRECT Syringes: 1 syringe (2.7 mL) B1

    DURA-CUF

    FDA UDI
    GE Medical Systems Information Technologies, Inc.·00840682110594·DURA-CUF, INFANT, 1 TB BAYONET, 08 - 13 CM, SINGLE

    LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·November 15, 2015

    SYRINGE 20ML LL 120/PKG

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 23, 2020

    MICRODEBRIDER 1898200T IGS M4

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·May 15, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 13, 2013

    ASR UNI FEMORAL IMPL SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 18, 2011

    PFC SIGMARP STB TB IN 3 10.0

    FDA Adverse Event
    Injury ·DEPUY CORK, A DIV. OF DEPUY ORTHOPAEDICS·Product code NJL·February 20, 2008

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·October 15, 2019

    LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V);

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

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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