BEUDAMED
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    NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and irritated anterior or front of nasal passages caused by dry climate and indoor heat.

    FDA Enforcement
    Class II ·Ongoing·Neilmed Pharmaceuticals Inc·February 12, 2025

    Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·February 28, 2024

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Salyer Prn Biomedical·March 13, 2013

    Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.

    FDA Enforcement
    Class II ·Terminated·Paa Laboratories Inc·July 24, 2013

    Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·April 29, 2020

    Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

    FDA Enforcement
    Class II ·Terminated·Corflex·January 13, 2016

    HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

    FDA Enforcement
    Class II ·Terminated·Corflex·January 13, 2016

    CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

    FDA Enforcement
    Class II ·Terminated·Corflex·January 13, 2016

    ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

    FDA Enforcement
    Class II ·Terminated·Corflex·January 13, 2016

    BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

    FDA Enforcement
    Class II ·Terminated·Corflex·January 13, 2016

    ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

    FDA Enforcement
    Class II ·Terminated·Corflex·January 13, 2016

    Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07

    FDA Enforcement
    Class II ·Terminated·New Era Orthopaedics, LLc·August 15, 2018

    CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

    FDA Enforcement
    Class II ·Terminated·Corflex·January 13, 2016

    Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-UPM; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-HC; ARTERIAL LINE KIT: 20 GA X 5IN (12 CM)/ASK-04020-HMC; RADIAL ARTERY CATHETER KIT: 20 GA X 30MM/ASK-04020-MMC; RA CATH KIT: 20 GA X 1-1/2IN (3.81 CM)/ASK-04020-SV; ARTERIAL CATH KIT: 20 GA X 5 IN (12 CM)/ASK-04100-AMC-S1; ARTERIAL CATHETER KIT: 20 GA X 12 CM/ASK-04100-NS; RADIAL ARTERY KIT/ASK-04500-AH; RAD ART:20GAX3.81CM / ART LINE:20GAX12CM/ASK-04500-HF-S; ARTERIAL LINE KIT: 1L 20 GA X 12 CM/ASK-04510-HA; ARTERIAL LINE KIT: 20 GA. X 5 IN (12 CM)/ASK-04510-HF; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-IHC1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-MSK2; ARTERIAL CATH KIT: 20GA X 5IN/ASK-04510-NS; ARTERIAL CATHETER KIT: 20 GA X 12 CM/FS-04510-S; ARTERIAL LINE KIT/HF-04510-1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-BSM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45CM)/ASK-04020-HH1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-JMH1; RA CATH KIT: 20 GA X 1-3/4 IN/ASK-04020-MAS; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-MCC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MHT; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MI; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MIHS; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MUSC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-NCB; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-SPH; RA CATH SET: 20 GA X 1-3/4IN (4.45CM)/ASK-04020-UPM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UR1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-X1A; RA CATH KIT: 20 GA X 1-3/4IN/WBH-04020-1; CVC KIT: 20 GA X 12CM/ASK-04510-UCLA; ARTERIAL ACCESS TRAY WITH .025IN SWG/ASK-04001-BW1

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026

    Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A; ARTERIAL LINE KIT/AK-04510-S; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HUMC; ARTERIAL LINE KIT: 18 GA X 6 IN (16 CM)/ASK-04018-OH1; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-BID; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-MAR; ARTERIAL LINE KIT: 20 GA X 5 IN/ASK-04020-PM4; RA CATH KIT: 20 GA X 1 1/2IN (3.81 CM)/ASK-04120-HF3; RA CATH SET: 20 GA X 2 1/2 IN (6.35 CM)/ASK-04120-UR; ARTERIAL CATH KIT: 20 GA X 3 1/16 IN/ASK-04125-MGH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04500-HFH4; ARTERIAL LINE KIT: 20GA X 5IN/ASK-04510-BID2; ARTERIAL LINE KIT: 20GA X 5IN (12 CM)/ASK-04510-EHP1; ARTERIAL LINE KIT/ASK-04510-FEM1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-HFH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04510-HFH4; ARTERIAL LINE KIT/ASK-04510-SE; ARTERIAL LINE KIT: 20 GA X 5 IN (12CM)/ASK-04510-TGH2; RA CATH KIT: 20 GA X 12 CM/NA-04550-1A; RA CATH KIT: 20 GA X 12 CM/NA-04550-X1A; RA CATH KIT: 18 GA X 1-3/4IN/AK-04018; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-C; RA CATH KIT: 20 GA X 1-1/2IN/AK-04120; RA CATH KIT: 22 GA X 1-3/8IN/AK-04122; RA CATH KIT: 20 GA X 1-1/2IN/AK-04220; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-AH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-ATH; RA CATH KIT: 20 GA X 1 3/4IN (4.45CM)/ASK-04020-AU2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-BHS; ARTERIAL CATHETERIZATION KIT/ASK-04020-BIDB2; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-CCD1; ARTERIAL CATHETERIZATION KIT/ASK-04020-CR; ART LINE KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-EUH2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FAM1; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FMC; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-KSF2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LM; RA CATH KIT: 20 GA X 1 3/4IN/ASK-04020-MCH1; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MIH1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-NWMX; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-PHP; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-RIHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-RMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-RU; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-SE; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-SHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-SRMC1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UCL1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-UMI; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-UN; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC1; RA CATH SET: 20 GA X 1-1/2IN (3.81CM)/ASK-04220-PSU; RA CATH KIT: 20 GA X 1-1/2 IN (3.81 CM)/ASK-04220-UCL1; RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-S1A; CVC KIT: 20 GA X 5 IN (12CM)/ASK-04550-JMC1; ARTERIAL ACCESS TRAY/ASK-04001-BW2; ARTERIAL ACCESS TRAY WITH .025 IN SWG/ASK-04001-WUH1; ARTERIAL LINE KIT/ASK-04510-HUM

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026

    Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM5; CATH SL 20 GA X 5 CM HYDROPHILIC/ASK-00520-JH; CATH S-L 20 GA X 5 CM HYDROPHILIC/ASK-00520-UHC; ARTERIAL LINE KIT: 20 GA x 5IN/ASK-00820-CL; RA CATH KIT: 20 GA X 8 CM X 12 CM/ASK-00820-WC; ARTERIAL CATHETERIZATION KIT/ASK-01218-HM; SAC KIT: 20 GA X 12CM/ASK-01220-HMH; ARTERIAL CATH KIT: 20GA X 12CM/ASK-01220-NWM; ARTERIAL CATH KIT: 20 GA X 12 CM/ASK-01220-UH; ARTERIAL CATH: 18 GA X 6 1/2IN/ASK-01618-AU; RA CATH KIT: 18 GA X 6 IN/ASK-01618-CL; ARTERIAL CATH KIT: 18 GA X 6 1/2 IN/ASK-01618-JH; ARTERIAL CATHETERIZATION KIT/ASK-01618-PH; ARTERIAL CATH KIT: 18 GA X 6 1/2IN/ASK-01618-RU; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HF; ARTERIAL CATH KIT: 18 GA X 6 IN (16 CM)/ASK-04018-NS; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-ST; RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04120-BGH; ART/VESS CATH KIT:20GAX4.45CM/20GAX12CM/ASK-04500-SM; ARTERIAL LINE KIT/ASK-04500-UCH; ARTERIAL LINE KIT/ASK-04510-EUH2; ARTERIAL LINE KIT: 20GA X 5IN (12CM)/ASK-04510-MS4; ARTERIAL LINE KIT/ASK-04510-UPM; ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-1A; ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-X1A; ARTERIAL CATH KIT: 22GA X 5CM/SAC-00522-1A ARTERIAL CATH KIT: 22 GA X 5CM/SAC-00522-X1A; ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-1A; ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-X1A; SAC KIT: 18 GA X 12CM/SAC-01218-1A; SAC KIT: 18 GA X 12CM/SAC-01218-X1A; SAC KIT: 20 GA X 12CM/SAC-01220-1A; SAC KIT: 20 GA X 12CM/SAC-01220-X1A; SAC KIT: 18 GA X 16CM/SAC-01618-1A; SAC KIT: 18 GA X 16CM/SAC-01618-X1A; ACCESS TRAY/UM-04018; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-ABM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-BGH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LOL; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MHS; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-MIB3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC1; RA CATH SET: 20 GA X 1 3/4 IN/ASK-04020-URMC; RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04220-FMH1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-1A; RA CATH KIT: 20 GA X 4.45 CM W BIO/NA-04020-B; RA CATH KIT: 20 GA X 4.45 CM W CHG/NA-04020-C; VESSEL CATH KIT: 20 GA X 5IN (12 CM)/ASK-04550-NYP; CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04300-PHP1; CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04301-TJ; ARTERIAL ACCESS KIT/ASK-04001-VAMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-WBH

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026