BEUDAMED
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    NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015

    NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015

    NobelReplace CC PMC RP 5.0x10mm, Article No. 37296.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015

    NobelReplace CC PMC NP 3.5x13mm, Article No. 37288.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015

    NobelReplace CC PMC RP 4.3x10mm, Article No. 37291.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015

    NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code DZE·March 9, 2015

    NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.

    FDA Recall
    Terminated ·NOBEL BIOCARE SERVICES AG Balz-zimmermannstrasse 7 Kloten Switzerland·Product code DZE·July 20, 2020

    Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels.

    FDA Recall
    Open, Classified ·Arrow International Inc·Product code DQX·December 12, 2019

    DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN), DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN), DigniCap Delta Small Cooling Wrap (LAB 20200616-01-EN, Quick Reference Guide DigniCap Delta (IFU-20190327-02-EN), The DigniCap Scalp Cooling System Training Guide- Global (TR-20200104-05-EN), The DigniCap Scalp Cooling System Training Guide TR-2019-0801-05-US, DigniCap Delta Procedural Expectations- Global (TR-20191028-03-EN), DigniCap Delta Procedural Expectations TR- 20190721-02-US, DigniCap Delta Small Wrap Protocol Global(TR-20200728-02-EN), DigniCap Delta Small Wrap Protocol TR-20200714-01-US, DigniCap Delta Training Tips Global (TR-20200420-04-EN), DigniCap Delta Training Tips TR-20191202-05-US,

    FDA Recall
    Terminated ·Dignitana, Inc.·Product code PMC·November 5, 2021

    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 Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code DQX·April 21, 2026

    CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DSI·November 12, 2019

    CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DSI·November 12, 2019

    ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DSI·November 12, 2019

    Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code GDR·May 11, 2017

    BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.

    FDA Recall
    Terminated ·Baylis Medical Company Inc. 5160 Explorer Drive #33 Mississauga Canada Ontario·Product code GXI·October 4, 2012

    ARTERIAL CATHETERIZATION KIT/Product SKU (Code) ASK-04100-AMC. Arterial catheterization kit

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·October 29, 2010

    First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B

    FDA Recall
    Terminated ·Ameditech Inc·Product code LDJ·August 18, 2020

    Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75

    FDA Recall
    Terminated ·Edwards Lifesciences Technology SARL·Product code DYG·November 27, 2006

    Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g. BASIN PACK h. BASIN SET i. SURGI START PACK j. PK, GEN-SET UP - MIDWEST k. SINGLE BASIN PACK-LF l. AGHM MINOR SINGLE PACK m. MINOR PACK n. SINGLE BASIN PACK o. MAJOR BASIN PACK p. BASIC SET UP-LF q. BASIC SET-UP-LF r. BASIN PACK s. MINOR BASIN t. AMC MAJOR BASIN u. AMC MAJOR BASIN

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code KDD·November 17, 2022

    LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO, Manufactured for Valleylab, a division of Tyco Healthcare Group LP, Boulder, CO. Manufactured by Covidien Medical Products (Shanghai) Manufacturing LLC, Building No. 10, 789 Puxing Road, Shanghai 201114, P.R. Chin., Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics, and tissue bundles.

    FDA Recall
    Terminated ·Covidien, PLC·Product code GEI·November 4, 2011