BEUDAMED
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    FX V135(TM) Shoulder Prosthesis

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOPHEN LMWH Control C3

    FDA UDI
    HYPHEN BIOMED·03663537007989·

    Ophthalmic Hooks

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114308·SINSKEY IOL HOOK ANG (BX/3)

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517110258·

    FILM PROCESSOR, MODEL LIFE RAY PRO 1000

    FDA 510(k)
    FDA Class 2 ·Radiology

    FINGER PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CASPIAN Spinal System

    FDA UDI
    VB Spine LLC·10888857242715·Lateral Hook Holder

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·August 18, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014

    UNKNOWN DEPUY POLY ACETABULAR LINER

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code HRY·July 12, 2013

    bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185

    FDA Recall
    Open, Classified ·Product code JWH·May 12, 2021

    DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980

    FDA Recall
    Open, Classified ·Product code JWH·May 12, 2021

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026