BEUDAMED
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    LOW PROFILE SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Liqui-Jet 2

    FDA UDI
    STERIS CORPORATION·00724995011840·Liqui-Jet 2 5-Gallon is a concentrated, alkalin...

    TULSA-PRO

    FDA UDI
    Profound Medical Inc·07540281000083·Cable - SE to FB, 25FT

    THERMOPLASTIC INSTRUMENT TRAY

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896053311·THERMOPLASTIC INSTRUMENT TRAY WITH SILICONE MAT

    Tasso Mini

    FDA UDI
    Tasso Inc.·00850038691141·

    ScrewPlant®/ ScrewPlus® Implant Closed-Tray Transfer

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307121114·

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383503136·Gutta Percha Points is used to root canal filin...

    ACT III VENTRICULAR CATHETER

    FDA 510(k)
    FDA Class 2 ·Neurology

    XTRAC EXCIMER LASER SYSTEM, MODEL AL7000

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

    TAPERLOC COMPLETE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·October 1, 2025

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

    HIRES 90K

    FDA Adverse Event
    Injury ·ADVANCED BIONICS, LLC.·Product code MCM·May 19, 2011

    TAPERLOC COMPLETE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 5, 2025

    VIRTUS PLUS II (model nos. 1380 and 1480) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . VIRTUS PLUS II pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available; these adapt the pacing rate to the patient's changing metabolic demand.

    FDA Recall
    Terminated ·Guidant Corporation·Product code LWP·July 18, 2005

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    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

    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