BEUDAMED
    23 results · 20ms · Sources: EU EUDAMED, US FDA

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    CARDIOPULMUNARY RESUSCITATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRA-THIN SDS BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 1, 2006

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code DQY·March 27, 2007

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code DQY·December 28, 2006

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code DQY·March 5, 2007

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 28, 2006

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP.·Product code DQY·April 12, 2007

    GEM III VR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code LWS·October 31, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·November 1, 2007

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 11, 2013

    VITEK® 2 AST-ST01 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code LON·October 24, 2017

    HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, Tests for feed water and rinse water down to 0.1 ppm (mg/l), packaged in bottles containing 100 strips each, 5 bottles per kit, Part #811909. The firm name on the label is Hach, Ames, IA. The product is used in measuring for low levels of total chlorine (including chloramines and free chlorine) in feed water used to prepare dialysate.

    FDA Recall
    Terminated ·Hach Co·Product code FKP·May 23, 2008

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·November 20, 2024

    HACH SteriChek Sensitive Total Chlorine Reagent Strips, Tests for water and rinse water down to 0.1 mg/l (ppm), packaged 1/100-strip btl. per carton, 12 cartons per shipping case, Product #821972. The firm name on the label is HACH Company, Ames, IA. The product is used in measuring for low levels of total chlorine (including chloramines and free chlorine) in feed water used to prepare dialysate.

    FDA Recall
    Terminated ·Hach Co·Product code FKP·May 23, 2008

    RPC E-Z Chek Sensitive Total Chlorine and Chloramines Test Strips, Tests Water for Total Chlorine & Chloramines down to 0.1 ppm (mg/l), packaged in a 1/100-strip bottle, 60 bottles per tray, 5 trays per shipping case, Product code K100-0106 (HACH Part #812004). The label shows the product is Manufactured for Reprocessing Products Corp. (RPC), Minneapolis, MN. The product is used in measuring for low levels of total chlorine (including chloramines and free chlorine) in feed water used to prepare dialysate.

    FDA Recall
    Terminated ·Hach Co·Product code FKP·May 23, 2008

    HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, tests for feed water and rinse water down to 0.1 ppm (mg/l), packaged in bags containing 1/100-strip bottle, one medicine cup, and one insert. Each bag is sealed and labeled "812144 SteriChek Sensitive, Bagged, " 56 bags per cardboard tray, 5 trays per shipping case. Product code 812144 The product is used in measuring for low levels of total chlorine (including chloramines and free chlorine) in feed water used to prepare dialysate.

    FDA Recall
    Terminated ·Hach Co·Product code FKP·May 23, 2008

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024