BEUDAMED
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    BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.

    FDA Enforcement
    Class II ·Terminated·BD Biosciences, Systems & Reagents·July 9, 2014

    1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·April 4, 2018

    Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.

    FDA Enforcement
    Class I ·Terminated·Maquet Datascope Corp - Cardiac Assist Division·May 28, 2014

    Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·April 20, 2016

    0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·July 22, 2015

    Altrix¿ Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician or clinician with prescription privileges determines that temperature therapy is necessary or desirable.

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·October 31, 2018

    REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.

    FDA Enforcement
    Class II ·Terminated·LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC·March 7, 2018

    Urology Pack, 900-2510, package contains: (2) TOWELS ABSORBENT 15X 20 UF (1) DRAPE LITHO 11 0" X 63" W/LEGG/POUCH FEN UF (10)GAUZE SPONGE 4" X 4" 12PL Y (1) GOWN XL SMS IMPERVIOUS REINFORCED UF (1) TUR Y SET 81 " 2.1M REGULAR CLAM (1) GOWN SURG REINFORCED LGE TOWEL & WRAP (1) TUBE SUCTION CONNE 1/4 X 12' UF (3) GEL SYRINGE 10cc PREFILLED (1) TABLE COVER REINFORCED 44 X 78 (1) SYRINGE 60ML LUER LOCK W/O NDL UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·January 8, 2020

    Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·January 8, 2020

    Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿ EXL with LM 00630414593500; Dimension¿ EXL with LM with STM 00630414593593; Dimension¿ RxL Max 00630414949789; Dimension¿ RxL Max HM 00630414949796; Dimension¿ RxL Max HM STM 00630414949819; Dimension¿ Xpand¿ Plus 00630414949833; Dimension¿ Xpand¿ Plus HM 00630414949840; Dimension¿ RxL Max Refurbished 00630414592947; Dimension¿ RxL Max HM Refurbished 00630414592954; Dimension¿ Xpand¿ Plus Refurbished 00630414592961; Dimension¿ Xpand¿ Plus HM Refurbished 00630414592978; Dimension¿ EXL with LM Refurbished 00630414000268; Dimension¿ 200 Refurbished 00630414010717;; Dimension¿ RxL Max w/o HM International 00630414949802; Dimension¿ RxL Max HM International 00630414945477; Dimension¿ RxL Max HM STM International 00630414949826; Dimension¿ Xpand Plus w/o HM International 00630414949857; Dimension¿ Xpand Plus w/HM International 00630414945484; Dimension¿ EXL with LM International 00842768030024; Dimension¿ EXL 200 International 00842768037214 Dimension¿ EXL with LM with STM International 00630414593609 The Dimension motor assembly is used in the Dimension Thermal Chamber Fan (ASSY BLOWER SNOUT) and is responsible for the intake and circulation of air inside the "Wok," a chamber within the Dimension instrument which enables greater temperature control of the testing environment.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·November 14, 2018

    Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 111800S, 111805S, 111810S, 111815S, 111820S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S & 121820S

    FDA Enforcement
    Class II ·Terminated·NewDeal SA·July 25, 2018

    UROLOGY PACK - (4) ABSORBENT TOWELS UF (2) GOWN SURGICAL POLY-REINF. BREATHABLE XL LEVEL IV (1) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F (1) TUR Y SET, 81 "2 .1M REGULAR CLAM (1) TABLE COVER 44" x 90" (1) DRAPE LITHO 11 0" X 63" WITH POUCH /LEGGING FEN (1) TUBE SUCTION CONNECT. Y." X 12' LIF (1) WASH BASIN ROUND 6QT (1 0) GAUZE SPONGE 4" X 4" 16PL Y LIF (1) BAG URINARY DRAINAGE 2000ml ANTI-REFLUX LIF (1) DRAPE LASER CAMERA W/EL UF (1) SYRINGE 1 Occ W/0 NDL LUER LOCK UF (1 ) UTILITY BOWL 32oz. (1) GEL SYRINGE 10cc PREFILLED (5) SPECIMEN CONTAINER 4oz. W/LID & LABEL L/F (1) WRAPPER 20" X 20" L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS IMPERV. REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (1) COVER TABLE REINF 50" X 90" LIF (1) TUBE SUCTION CONNECT. W' X 12' LIF (1) GOWN SURG REINF XL T/WRAP (20) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) PENCIL CAUTERY HAND SWITCHING (1) PVP PAINT 8" STICK SPONGE (1) PVP SCRUB 8" STICK SPONGE (1) SYRINGE 20cc W/0 NDL LUER LOCK LIF (1) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) PRE PAD WITH CUFF (1) PACKING VAGINAL XRD 4" X 36" 8PLY (2) PAD OBSTETRICAL XL (1) CATHETER 2/W 16Fr. PRESS W/UBAG 2000ML (1) TIME OUT BEACON NON WOVEN LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients.

    FDA Enforcement
    Class II ·Terminated·Respironics California Inc·December 3, 2014