BEUDAMED
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    EXPORT XT CATHETER, EXPORT AP CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06936735471072·Non-Invasive BP Air Hose Adaptor NIBP Y adaptor...

    FERTILITE OV

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MI VARNISH

    FDA 510(k)
    FDA Class 2 ·Dental

    BUBBLE CPAP SYSTEM

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·October 22, 2012

    SAGITTAL SAW ATTACHMENT

    FDA Adverse Event
    Malfunction ·Product code HWE·September 3, 2014

    BUBBLE CPAP SYSTEM

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZD·November 12, 2012

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2013

    SYNCHRON LX NO FOAM

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code LDT·June 10, 2011

    PULSE GEN MODEL 102R

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·August 15, 2008

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·January 14, 2013

    MEGA 7.5FR. 40CC

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 10, 2020

    Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R PMA; L-1189-04-S D17TCJLRT 35Q-73R PMA; L-1189-15-S D71TCB5L252RT 35Q-17Q EXPORT; L-1189-16-S D71TCD5L252RT 35Q-37Q EXPORT; L-1189-17-S D71TCF5L252FT 35Q-57Q EXPORT; L-1189-03-S D71TFL252RT 35R-53R EXPORT; L-1192-03-S D71TFL252RT 35R-53R EXPORT; L-1192-15-S D71TB5L252RT 35R-17R EXPORT; L-1192-16-S D7ITD5L252RT 35R-37R EXPORT; L-1189-02-SI D17TCDLRTI N/A IDE; L-1189-15-SI D71TCB5L252RTI N/A IDE; L-1189-16-SI D71TCD5L252RTI N/A IDE; L-1189-17-SI D71CF5L252RTI N/A IDE Navistar LABEL US Part Number# EU CATALOG # L-1192-17-S D71TF5L252RT 35R-57R EXPORT; L-1197-14-S NI75TCBH 34H-17M PMA; L-1197-15-S NI75TCCH 34H-27M PMA; L-1197-16-S NI75TCDH 34H-37M PMA; L-1197-17-S NI75TCFH 34H-57M PMA; L-1197-18-S NI75TCJH 34H-J7M PMA; L-1208-05-S NS75TBCT252HS 34G-17M PMA; L-1208-06-S NS75TCCT252HS 34G-27M PMA; L-1208-07-S NS75TDCT252HS 34G-37M PMA; L-1208-08-S NS75TFCT252HS 34G-57M PMA; L-1197-14-SI NI75TCBHI N/A IDE; L-1197-15-SI NI75TCCHI N/A IDE; L-1197-16-SI NI75TCDHI N/A IDE; L-1197-17-SI NI75TCFHI N/A IDE; L-1197-18-SI NI75TCJHI N/A IDE; L-1208-05-SI NS75TBCT252HSI N/A IDE; L-1208-06-SI NS75TCCT252HSI N/A IDE; L-1208-07-SI NS75TDCT252HSI N/A IDE; L-1208-08-SI NS75TFCT252HSI N/A IDE

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code LPB·August 8, 2005

    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

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

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018