BEUDAMED
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    Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in conjunction with the SAGE CSC Freezing Medium Kit (ART-8017).

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code MQL·August 25, 2016

    Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertilization, Inc. A CooperSurgical Company 95 Corporate Drive Trumbull, CT 06611 USA

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code MQL·August 25, 2016

    Sydney IVF Culture Oil, REF, K- SICO- 50, 50 mL. and K-SICO-200, 200 mL,Store at 2-8 C, Sterile, Cook Medical, William A Cook Australia LTD, Product Usage: Culture oil is intended to be used as an oil overlay for cultures of gametes, zygotes, or embryos in assisted reproductive technology (ART) and micro manipulation procedures. It is used to reduce the osmotic stress due to evaporation and to reduce pH fluctuations.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MQL·February 15, 2012

    MediCult Vitrification Cooling Media, Model Number 12284001F

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code MQL·September 8, 2020

    COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software

    FDA Enforcement
    Class I ·Terminated·Beckman Coulter Inc.·November 28, 2018

    1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics

    FDA Enforcement
    Class I ·Terminated·Beckman Coulter Inc.·November 28, 2018

    CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies. Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

    FDA Enforcement
    Class II ·Terminated·Corflex·January 13, 2016

    Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union and delayed union Periprosthetic fractures Surgically created defects such as osteotomies. Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union and delayed union Periprosthetic fractures Surgically created defects such as osteotomies.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 3, 2018

    Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.

    FDA Recall
    Terminated ·WOM World of Medicine AG Salzufer 8 Berlin Germany·Product code HIG·August 14, 2019

    07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

    FDA Enforcement
    Class II ·Terminated·Vascular Technology, Inc.·July 16, 2014

    Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.

    FDA Enforcement
    Class II ·Terminated·Arthrex, Inc.·April 21, 2021

    07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

    FDA Recall
    Terminated ·Vascular Technology, Inc.·Product code DPW·May 28, 2014

    Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code HRS·March 11, 2021

    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060). EQL/20/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQY·September 29, 2009

    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-112 (M001171120). EQL/40/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQY·September 29, 2009

    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-108 (M001171080). EQL/27/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQY·September 29, 2009

    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-110 (M001171100). EQL/33/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQY·September 29, 2009

    Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.

    FDA Enforcement
    Class II ·Terminated·WOM World of Medicine AG·October 9, 2019

    Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

    FDA Enforcement
    Class II ·Terminated·Corflex·January 13, 2016

    HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

    FDA Enforcement
    Class II ·Terminated·Corflex·January 13, 2016