BEUDAMED
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    HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.

    FDA Enforcement
    Class II ·Terminated·Hamilton Medical, Inc.·November 13, 2013

    HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.

    FDA Recall
    Terminated ·Hamilton Medical, Inc.·Product code CBK·September 26, 2013

    HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes.

    FDA Enforcement
    Class II ·Terminated·Horiba Instruments, Inc dba Horiba Medical·April 24, 2013

    HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes.

    FDA Recall
    Terminated ·Horiba Instruments, Inc dba Horiba Medical·Product code JGS·March 20, 2013

    Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

    FDA Recall
    Terminated ·Keystone Dental Inc·Product code DZE·May 1, 2018

    Hill-Rom TotalCare Bed, Model P1900. The TotalCare (R) Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare (R) Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post

    FDA Recall
    Terminated ·Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006·Product code FNL·March 9, 2009

    Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthesis

    FDA Recall
    Terminated ·Biomet, Inc.·Product code N/A·April 17, 2020

    Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosthesis

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JWH·April 17, 2020

    Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis

    FDA Recall
    Terminated ·Biomet, Inc.·Product code MBH·April 17, 2020

    Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JDI·April 17, 2020

    Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM 189048 Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM 189082 Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JWH·April 17, 2020

    Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip arthroplasty.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LZO·April 17, 2020

    Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code PHX·April 17, 2020

    Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM 189700 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 79 MM 189704 Vanguard Knee System, CR Mono Lock Tibial Bearing, 14 MM X 79 MM Product Usage: Knee prosthesis

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JWH·April 17, 2020

    Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, non-torque-limiting.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code KWS·November 25, 2020

    BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJT·September 18, 2019

    BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJT·September 18, 2019

    XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJT·September 18, 2019

    BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJT·September 18, 2019

    Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM 155344 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 75 MM 155346 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 75 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155328 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 70 MM 155388 Knees AGC Knee System PS Molded Tibial component, 18 MM X 85 MM Product Usage: Knee prosthesis

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JWH·April 17, 2020