BEUDAMED
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    LANX SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Premier

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00856402006290·Decan Stopper Size 4 Closure Full

    "Lucy" Protective Eyewear

    FDA UDI
    HAGER WORLDWIDE, INC.·D2481009350·Protective eyewear

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964065415·Endo Carry-on Procedure Kit includes Lubricant,...

    V.A.T.S. DISSECTING CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921009350·V.A.T.S. DISSECTING CLAMP CURVED WITH RATCHET S...

    V.A.T.S. DISSECTING CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896003910·V.A.T.S. DISSECTING CLAMP CURVED WITH RATCHET S...

    Copper Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989027488·COPPER NITI 35 BAF 19X025UP LG PK10

    Mariner MIS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981294991·Stylet Shuttle, 35mm

    ZAVATION

    FDA UDI
    Zavation LLC·00842166191846·Drill - Adjustable Guide Posterior Cervical

    KFA-63 KNEE AND FOOT ARRAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    BRITESMILE BARRIER MATERIAL

    FDA 510(k)
    FDA Class 1 ·Dental

    GYNECARE TVT-ABBREVO MINI LCM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·November 30, 2021

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013

    SMART CONTROL NITINOL STENT SYSTEM

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIO·September 19, 2014

    EV3 NEUROVASCULAR

    FDA Adverse Event
    Injury ·Product code KRA·May 18, 2011

    Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH; Go Pump Kit 510349-BP, Epidural Catheter, BioPatch; Go Pump Kit 510642 Disposable Single Infusion Pump, Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. The medication is delivered via tubing to the surgical site at a very slow rate

    FDA Enforcement
    Class I ·Terminated·Symbios Medical Products, LLC·June 12, 2013

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)

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

    Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

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