BEUDAMED
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    Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse CoOximeter

    FDA Recall
    Terminated ·Masimo Corporation·Product code DQA·February 2, 2006

    Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 22, 2014

    ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cutting shaping bone including spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBE·April 13, 2015

    ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cutting shaping bone including spine and cranium.

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

    MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]. General Hospital Use.

    FDA Recall
    Terminated ·Owens & Minor Distribution, Inc.·Product code KGX·November 17, 2015

    MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.

    FDA Recall
    Terminated ·Owens & Minor Distribution, Inc.·Product code KGX·November 17, 2015

    MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.

    FDA Recall
    Terminated ·Owens & Minor Distribution, Inc.·Product code KGX·November 17, 2015

    ASC2000 Ambulatory Surgical Table. Model #MTS110003. The device is used to provide complete and flexible positioning for surgical procedures.

    FDA Recall
    Terminated ·Steris Corp·Product code GDC·April 17, 2009

    CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321

    FDA Recall
    Terminated ·Carolina Liquid Chemistries·Product code DIC·January 16, 2019

    Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DIC·January 11, 2019

    Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code DIC·February 14, 2020

    OPERON D850 Surgical Table Product Usage: Surgical Table

    FDA Recall
    Terminated ·Berchtold Corp.·Product code GDC·April 16, 2012

    The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.

    FDA Recall
    Terminated ·Steris Corporation·Product code GDC·October 10, 2014

    TDx/TDxFLx REA Ethanol, list 9545-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code DIC--·December 5, 2003

    Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables

    FDA Recall
    Terminated ·Berchtold Corp.·Product code GDC·March 12, 2013

    STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. It accommodates all general surgical procedures including but not limited to, cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmologic, orthopedics and other procedures requiring intraoperative fluoroscopic C-arm imaging and also supports laparoscopic surgical technique for the largest surgical patients. The 5085SRT table is a variation of the 5085 table that enables patient transport on hard level surfaces within the surgical suite (from pre-operative areas to the operating room and again from the operating room to post operative recovery).

    FDA Recall
    Terminated ·Steris Corporation·Product code GDC·April 6, 2012

    Operon Electrical Operating Room Table. The device is used as an electrical operating room table.

    FDA Recall
    Terminated ·Berchtold Corp.·Product code GDC·February 2, 2009

    CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321

    FDA Recall
    Terminated ·Carolina Liquid Chemistries·Product code DIC·January 16, 2019

    Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.

    FDA Recall
    Terminated ·Mizuho OSI·Product code GDC·December 14, 2015

    Cmax Surgical Table, Model No. 2182625, Manufactured by STERIS Corporation, 2720 Gunter Park East, Montgomery, AL 36109 USA, TEL: 334 277 6660, FAX: 334 271 5450

    FDA Recall
    Terminated ·Steris Corporation·Product code GDC·February 6, 2007