BEUDAMED
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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·September 28, 2016

    ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and cranium.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·August 5, 2015

    Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGICAL ASC KIT 573343 7499-88 SURGICAL KIT with Light Gloves 573346 7499-TLG Surgical Kit with Edge 573359 7499-HLW Surgical KIT 573368 7494-CAB2 SURGICAL KIT 573776 7520-BHP SURGICAL KIT 573777 7527-BHB SURGICAL KITS 573798 7496-8KB Surgical KIT 31144507 7519 Minor Surgical Kit 31175089 7497-8T6 Surgical Kit 31321097 7697 Surgical Set Up Kit 31451480 7493-SFW SURGICAL KIT 31460432 7596-SHH Surgical KIT 50000947 7413-CAD Surgical KIT 50001029 7417-PCP Surgical KIT 50001052 7427-CFS Surgical KIT

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·July 29, 2015

    Temporary Titanium Abutments

    FDA Enforcement
    Class II ·Ongoing·DDS Lab·February 12, 2025

    Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia.

    FDA Enforcement
    Class II ·Terminated·SALTER LABS·July 4, 2012

    Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.

    FDA Enforcement
    Class II ·Terminated·Salter Labs·July 30, 2014

    NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.

    FDA Enforcement
    Class II ·Terminated·Salter Labs·September 23, 2015

    Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line.

    FDA Enforcement
    Class II ·Terminated·SALTER LABS·November 27, 2013

    T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.

    FDA Enforcement
    Class II ·Terminated·Salter Labs·February 17, 2016

    Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities.

    FDA Enforcement
    Class II ·Terminated·Wexford Labs Inc·November 27, 2013

    Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.

    FDA Enforcement
    Class II ·Terminated·Lab Vision Corporation·January 22, 2014

    miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.

    FDA Enforcement
    Class II ·Terminated·Miramar Labs, Inc.·November 18, 2015

    Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

    FDA Enforcement
    Class II ·Completed·Bio-Rad Labs·May 6, 2020

    AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider.

    FDA Enforcement
    Class II ·Terminated·Ansh Labs, LLC·January 20, 2021

    Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DIAG/CV CATH, Model Number:DYKMBNDL153; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number:DYKMBNDL4A; 6) KIT ACES INSERT PERCUTANEOUS T, Model Number:DYKMBNDL4B; 7) VEIN PROCEDURE KIT, Model Number:DYNDA2076C; 8) CARDIAC CATH PACK-LF, Model Number:DYNJ0150605AC; 9) CARDIAC CATH PACK-LF, Model Number:DYNJ0368386D; 10) CATH LAB PACK-LF, Model Number:DYNJ0648473Y; 11) NBMC CATH PACK-LF, Model Number:DYNJ0803367I; 12) RADIOLOGY PACK-LF, Model Number:DYNJ0928124C; 13) ANGIO PACK-LF, Model Number:DYNJ0954970I; 14) SPECIALS TRAY RADIOLOGY, Model Number:DYNJ16803D; 15) CARDIAC CATH PACK, Model Number:DYNJ19946M; 16) CATH LAB PACK, Model Number:DYNJ30955I; 17) CATH LAB PACK, Model Number:DYNJ31773K; 18) CATH PACK-LF, Model Number:DYNJ33061D; 19) DB CCL OAKWOOD PACK-LF, Model Number:DYNJ33620D; 20) CARDIAC CATH PACK MRH-LF, Model Number:DYNJ35300M; 21) CATH LAB PK, Model Number:DYNJ35643C; 22) CARDIAC CATH PACK-LF, Model Number:DYNJ39066B; 23) ANGIOGRAPHY PACK, Model Number:DYNJ42134G; 24) CATH PACK-LF, Model Number:DYNJ43101C; 25) OR ANGIO PACK-LF, Model Number:DYNJ43415D; 26) OR ANGIO PACK-LF, Model Number:DYNJ43415F; 27) ANGIOPLASTY PACK, Model Number:DYNJ44700J; 28) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJ44850J; 29) RADIOLOGICAL PACK, Model Number:DYNJ44889O; 30) CARDIAC CATH PACK, Model Number:DYNJ47370B; 31) ANGIOGRAPHY PACK, Model Number:DYNJ53129D; 32) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJ56772G; 33) DR. MOHINDRA PACK, Model Number:DYNJ57602G; 34) NE ENDO VASCULAR PACK, Model Number:DYNJ57940B; 35) CARDIAC CATH PACK - Q1, Model Number:DYNJ58048C; 36) OR ANGIO, Model Number:DYNJ59931B; 37) LPCH PERRY CATH PACK, Model Number:DYNJ67378C; 38) HOSPITAL REGIONAL DE CONCEPCIO, Model Number:DYNJ67918A; 39) CATH LAB PACK, Model Number:DYNJ68633; 40) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197B; 41) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197C; 42) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197D; 43) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197F; 44) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197G; 45) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197I; 46) BASIC CARDIAC CATH PACK, Model Number:DYNJ81593B; 47) CATH LAB PACK, Model Number:DYNJ83073; 48) UMC EL PASO CATH PACK, Model Number:DYNJ83089; 49) DR. MOHINDRA PACK, Model Number:DYNJ83819A; 50) VZ VAS/ANG PACK, Model Number:DYNJ83981; 51) WCPN CARDIOLOGY PACK, Model Number:DYNJ84539; 52) CATH LAB, Model Number:DYNJ85511; 53) CATH LAB, Model Number:DYNJ85511A; 54) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJT1520K; 55) CVC BUNDLE KIT, Model Number:ECVC6225A; 56) CVC 3L 7F 20CM VANTEX, Model Number:ECVC7265A; 57) ANGIOGRAPHY TRAY, Model Number:MNS9130

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 13, 2026

    Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·September 24, 2014

    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F DYNJ47665G ANGIO KIT PACK DYNJ83746 DYNJ83746A ANGIO PACK DYNJ30565G DYNJ51239C DYNJ66631A DYNJ69200A DYNJ88276 ANGIO PHC DYNJ37485D ANGIO TRAY 116118 DYNJ37724K ANGIO TRAY NO LIDO DYNJ85557 DYNJ85557B ANGIOGRAM-30852 DYNJVB91148A ANGIOGRAPHY DRAPE PACK-LF DYNJ0373221P ANGIOGRAPHY PACK DYNJ17218R DYNJ44293F DYNJ44293G DYNJ44293J DYNJ83516 ANGIOGRAPHY PACK-LF DYNJ0854485X ARTERIOGRAM DYNJ28082I BASIC HEART CATH PACK DYNJVB1075B CARDIAC CATH DYNJ910293 CARDIAC CATH PACK DYNJ68653B DYNJ68653C CARDIAC CATH PACK-LF DYNJ85258 CATH LAB (EP) PACK DYNJ65162B CATH LAB ANGIO PACK-LF DYNJ0545064AA CATH LAB ANGIO TRAY DYNJ83506A CATH LAB PACK DYNJ66366D DYNJ66366F DYNJT2202U CATH LAB PROCEDURE PK DYNJ57723C CATH LAB TRAY DYNJ37389P DYNJ37389Q CATH PACK DYNJ62595C DYNJ62595D DYNJ69997A HEART CATH PACK DYNJ85783 HEART CATH-SFMC DYNJ82434 INTERVENTIONAL PACK DYNJ56666D INTERVENTIONAL PACK-LF DYNJ37211J INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AI IR PACK DYNJ36752B JUDKINS PACK DYNJ51126C M&E ANGIOGRAPHY PK DYNJ83812 NEURO ANGIO PACK DYNJ51697C NEUROLOGICAL CATH PACK DYNJ63434D OR HYBRID-MRMC DYNJ907758C PTCA PACK DYNJ55359C DYNJ55359D RADIOLOGY ANGIO MAJOR PACK DYNJ62858C SURGERY ANGIO PACK-LF PHS677784013B ANGIO ARTERIOGRAM PACK-LF DYNJ0774026J ANGIO IR PACK DYNJ31196G ANGIO PACK DYNJ30565F, DYNJ69200 ANGIOGRAM PACK-LF DYNJ21574K, DYNJ21574L ANGIOGRAPHY PACK DYNJ26855G, DYNJ26855I BGMC CARDIAC CATH PACK-LF DYNJ0664960D CARDIAC CATH DYNJ59898B CARDIAC CATH PACK DYNJ68653A, DYNJ69150A CATH LAB ANGIO PACK-LF DYNJ0545064Y CATH LAB PACK DYNJ28428F, DYNJ80457 CATH LAB-LF DYNJ51423F CATH PACK DYNJ62595B, DYNJ62983A CATH PROCEDURAL TRAY DYNJ43580D GENERAL ANGIO PACK DYNJ57760C HEART CATH PACK DYNJ69318 HEART CATH TRAY DYNJ53251J, DYNJ81557 IR PACK DYNJ65312 MAIN OR CATH LAB DYNJ61373A M CARDIAC CATH DYNJ58339A N CATH PACK NG140A OR RADIOLOGY PACK DYNJ62747 RADIOLOGY PACK DYNJ42633C R ANGIO PACK DYNJ36338C SPECIAL TRAY DYNJ65756A TAVR PACK DYNJ69246

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·April 29, 2026

    Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for drawing blood. One of the tubes is the recalled BD blue top citrate tube (5 tubes). These tubes were manufactured by BD, Franklin Lakes, NJ. The kit is used by health care providers when treating patients.

    FDA Enforcement
    Class II ·Terminated·Heritage Labs International LLC·April 24, 2013

    Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.

    FDA Enforcement
    Class II ·Terminated·Hand Biomechanics Lab Inc·October 26, 2016

    BD Kiestra" ReadA; Catalog No.: 446948.

    FDA Enforcement
    Class II ·Ongoing·BD KIESTRA LAB AUTOMATION·April 8, 2026