BEUDAMED
    8 results · 14ms · Sources: EU EUDAMED, US FDA

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

    Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc·July 19, 2017

    Spectrum Medical Quantum Standard heat exchanger

    FDA Enforcement
    Class II ·Terminated·QURA S.R.L.·August 18, 2021

    Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·July 16, 2014

    ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium concentration in human serum, plasma or urine.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·August 21, 2013

    AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite.

    FDA Enforcement
    Class II ·Terminated·Ultradent Products, Inc.·June 27, 2012

    Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or lift patients under the direct supervision of trained staff. Model 392000-1 is equipped with a scale.

    FDA Enforcement
    Class II ·Terminated·Penner Mfg Inc·April 1, 2015

    - Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122465, 122434, 122665 - AcromioBlaster Burr (Sage Green) 4.0mm Ref. 7205668 Lot 122590, 123270 - Acromionizer Bur, Barrel, (Mauve) 4.0mm Ref. 7205326 Lot 122609 - BoneCutter Blade, Full Radius, Series 3000 (Orange/Black) 5.5mm Ref. 7206010 Lot 122609 - CoolCut Bone Cutter (Blue/Orange) 3.8mm Ref. AR-8380BC Lot 122631 arthoscope - CoolCut Bone Cutter (Blue/Orange) 4.0mm Ref. AR-8400BC Lot 122631 - CoolCut Bone Cutter (Blue/Orange) 5.5mm Ref. AR-8550BC Lot 122631 - CoolCut Dissector (Blue/Blue) 3.5mm Ref. AR-8350DS Lot 123190 - CoolCut Dissector (Blue/Blue) 4.0mm Ref. AR-8400DS Lot 123190, 122493, 122631 - CoolCut Dissector (Blue/Blue) 5.0mm Ref. AR-8500DS Lot 122493 - CoolCut Dissector Small Joint (Blue/Blue) 3.0mm Ref. AR-7300DS Lot 123190, 122493, 122631, - CoolCut Excalibur (Blue/Beige) 3.8mm Ref. AR-8380EX Lot 122631 - CoolCut Excalibur (Blue/Beige) 4.0mm Ref. AR-8400EX Lot 122631 - CoolCut Oval Burr (12 Flutes) (Blue/White) 5.5mm Ref. AR-8550OBT Lot 122631 - CoolCut Oval Burr (8 Flute) (Blue/White) 4.0mm Ref. AR-8400OBE Lot 122493, 122631, 122279 - CoolCut Oval Burr (8 Flute) (Blue/White) 5.0mm Ref. AR-8500OBE Lot 122493 - CoolCut Round Burr (8 Flute) (Blue/Red) 5.0mm Ref. AR-8500RBE Lot 123190 - CoolCut Sabre (Blue/Green) 3.8mm Ref. AR-8380SR Lot 122493 - DYONICS ELITE Achromobacter (Sage Green) 4.0mm Ref. 72200730 Lot 122665 - Elite* AcromioBlaster Burr (Brick Red/Yellow) 5.5mm Ref. 72200731 Lot 122665 - Formula Aggressive Plus Cutter (Beige/Blue) 5.5mm Ref. 375-564-000 Lot 122309 - Formula Aggressive Plus Cutter (Dk. Blue/Lt. Blue) 5.0mm Ref. 375-554-000 Lot 122490 - Formula Aggressive Plus Cutter (Yellow/Blue) 3.5mm Ref. 375-534-000 Lot 122518, 122309 - Formula Aggressive Plus Cutter Large Hub, (Red/Blue) 4.0mm Ref. 375-544-000 Lot 122594, 122588, 122518, 122278 - Formula Barrel Bur, 12-Flute (Beige/Beige) 5.5mm Ref. 375-951-012 Lot 122278 - Formula Barrel Bur, 12-Flute (Blue/Blue) 5.0mm Ref. 375-951-112 Lot 122594 - Formula Barrel Bur, 12-Flute (Red/Red) 4.0mm Ref. 375-941-012 Lot 122594, 122518 - Formula Barrel Bur, 6-Flute (Beige/Beige) 5.5mm Ref. 375-951-000 Lot 122588 - Formula Barrel Bur, 6-Flute (Red/Red) 4.0mm Ref. 375-941-000 Lot 122588 - Formula Full Radius Cutter, Small Joint, (Grey) 2.5mm Ref. 375-627-000 Lot 122594 - Formula Hooded Abrasion Bur, Small Joint, (Orange) 3.0mm Ref. 375-647-000 Lot 122518 - Formula Resector Cutter (Red/Black) 4.0mm Ref. 375-542-000 Lot 122588 - Formula Resector Cutter (Yellow/Black) 3.5mm Ref. 375-532-000 Lot 122594, 122490, 122588 - Formula Round Bur, 12-Flute (Beige/Beige) 5.5mm Ref. 375-950-012 Lot 122278 - Formula Round Bur, 12-Flute (Red/Red) 4.0mm Ref. 375-940-012 Lot 122594 - Formula Round Bur, 6-Flute (Blue/Blue) 5.0mm Ref. 375-950-100 Lot 122490 - Formula Round Bur, 6-Flute (Red/Red) 4.0mm Ref. 375-940-000 Lot 122518 - Formula Slotted Whisker (Red/Red) 4.0mm Ref. 375-548-000 Lot 122594 - Formula Tomcat Cutter (Red/White) 4.0mm Ref. 375-545-000 Lot 122588 - Formula Tomcat Cutter (Yellow/White) 3.5mm Ref. 375-535-000 Lot 122588 - Full Radius Blade (Yellow) 4.5mm Ref. 7205306 Lot 122347, 122454, 122609, 123270, 122665 - Full Radius Blade, (Beige) 3.5mm Ref. 7205305 Lot 122609, 122665 - Full Radius Blade, (Orange) 5.5mm Ref. 7205307 Lot 122665 - Full Radius ELITE Blade (Beige) 3.5mm Ref. 7210751 Lot 122465, 122665 - Full Radius Mini Blade, 7cm Length (Red) 2.9mm Ref. 3419 Lot 122609 - Full Radius Resector Large Hub, Sterling, Shaver, (Yellow) 4.2mm Ref. 9247A Lot 123263, 122592, 123353 - Full Radius Resector, Large Hub, Merlin, Pre-Bent 15 Degree, (Yellow/Black) 4.2mm Ref. C9241 Lot 123263 - Full Radius Resector, Sterling, Large Hub, (Yellow) 3.5mm Ref. C9248 Lot 123263, 122592, 122511 - Gator B

    FDA Enforcement
    Class II ·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013