BEUDAMED
    587 results · 10ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299

    FDA Enforcement
    Class II ·Terminated·Microbiologics Inc·March 9, 2022

    112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 15, 2018

    159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, 3 Pre-Pierced Ports, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 15, 2018

    Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·November 29, 2017

    Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·June 16, 2021

    LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299

    FDA Enforcement
    Class II ·Terminated·Microbiologics Inc·March 9, 2022

    Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, CareFusion, Boss Instruments, and Medline Industries brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 15, 2018

    Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459241(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-125, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459258(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-132, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459265(17)211129(10)00000-00 Product Usage: The AXS Vecta Aspiration System, including the AXS Vecta Aspiration Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·April 8, 2020

    125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 3 Gang 4-Way Stopcock w/Baseplate, Rotating Luer, 3 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 15, 2018

    132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 15, 2018

    139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w/2 4-Way Stopcocks w/Baseplate, 1o2¿ Valve, 2 Clave¿, Pre-Pierced Port, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 15, 2018

    Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating Luers, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 15, 2018

    Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration sets are intended for the infusion and withdrawal of fluids. Drip Chamber, Rotating Luer, Bag Hanger, Item No. 011-CL3341.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·April 6, 2016

    Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·December 21, 2016

    Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFusion brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    Minor Lap Pack, Kit number AMS2624 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion, Boss Instruments, Millennium Surgical, Prezio Health, and Stealth Surgical brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014