BEUDAMED
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    Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm Bipolar Cap, ID28mm, OD52mm Bipolar Cap, ID28mm, OD54mm Bipolar Cap, ID28mm, OD56mm

    FDA Enforcement
    Class II ·Terminated·Orthopedic Alliance LLC·June 5, 2013

    IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S; IMPRESSION CAP,CONT,5.5MM, ANG, REF ZOCIMP5A; IMPRESSION CAP, CONT, 5.5MM, REF ZOCIMP5S; MPRESSION CAP, CONT, 6.5MM,ANG, REF ZOCIMP6A; IMPRESSION CAP, CONT, 6.5MM, REF ZOCIMP6S

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·October 4, 2017

    Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm Bipolar Cap, ID28mm, OD52mm Bipolar Cap, ID28mm, OD54mm Bipolar Cap, ID28mm, OD56mm

    FDA Recall
    Terminated ·Orthopedic Alliance LLC·Product code KWY·February 20, 2013

    IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S; IMPRESSION CAP,CONT,5.5MM, ANG, REF ZOCIMP5A; IMPRESSION CAP, CONT, 5.5MM, REF ZOCIMP5S; MPRESSION CAP, CONT, 6.5MM,ANG, REF ZOCIMP6A; IMPRESSION CAP, CONT, 6.5MM, REF ZOCIMP6S

    FDA Recall
    Terminated ·Zimmer Dental Inc·Product code NDP·July 10, 2017

    LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 13mm non-anodized anchor bolt body with anchor bolt cap containing a green gasket and silicone cap, 26mm non-anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap - Product Usage: The Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode. Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes.

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·August 14, 2019

    Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile

    FDA Enforcement
    Class II ·Terminated·Baxter Corporation Englewood·December 31, 2014

    050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe¿ Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·July 28, 2021

    Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000

    FDA Enforcement
    Class II ·Terminated·Cardinal Scale Mfg Co·June 7, 2017

    COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·January 2, 2013

    ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP 10MM STER TROC END CAP 15MM STER TROC END CAP 20MM STER TROC END CAP 25MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 4, 2018

    Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer''s CLINITUBES kits. The end caps are packaged in bags. These bags are placed in the capillary tube kit which also contains: capillary tubes, end caps, mixing wires, and a magnet. Each kit may contain 1 or 5 bags depending on the kit model. Each bag contains: 110 Green caps per bag and 160 Red caps per bag.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code GIO·March 22, 2006

    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·April 27, 2022

    LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 13mm non-anodized anchor bolt body with anchor bolt cap containing a green gasket and silicone cap, 26mm non-anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap - Product Usage: The Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode. Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes.

    FDA Recall
    Terminated ·Ad-Tech Medical Instrument Corporation·Product code GZL·June 18, 2019

    Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.

    FDA Enforcement
    Class II ·Terminated·Vygon U.S.A.·April 17, 2019

    Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.

    FDA Enforcement
    Class II ·Terminated·Vygon U.S.A.·April 17, 2019

    Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile

    FDA Recall
    Terminated ·Baxter Corporation Englewood·Product code KYX·December 4, 2014

    050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDJ·April 28, 2021

    Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000

    FDA Recall
    Terminated ·Cardinal Scale Mfg Co·Product code FRI·December 23, 2015

    COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code JJH·October 11, 2012

    ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP 10MM STER TROC END CAP 15MM STER TROC END CAP 20MM STER TROC END CAP 25MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code HSB·December 20, 2017