BEUDAMED
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    PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5 FR, STERILE, 1 EA, SCALPEL, #11SS, STERILE, 1 EA, SUTURE, NYLON, 18", 2-0, REVERSE CUTTING, STERILE 1 EA, THREE QUARTER DRAPE, STERILE 1 EA, INSERT, SALINE 1 EA, INSERT, CLAMP 1 EA UDI: (01) 0 0863092 00010 1

    FDA Enforcement
    Class II ·Terminated·Prytime Medical Devices, Inc.·February 17, 2021

    PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5 FR, STERILE, 1 EA, SCALPEL, #11SS, STERILE, 1 EA, SUTURE, NYLON, 18", 2-0, REVERSE CUTTING, STERILE 1 EA, THREE QUARTER DRAPE, STERILE 1 EA, INSERT, SALINE 1 EA, INSERT, CLAMP 1 EA UDI: (01) 0 0863092 00010 1

    FDA Recall
    Terminated ·Prytime Medical Devices, Inc.·Product code OFC·December 14, 2020

    Liko Universal Sling Bar 450 Quick Release Hook (QRH) Product Number: 3156085

    FDA Recall
    Terminated ·Liko, Inc.·Product code FRW·June 13, 2007

    IMS Patient Scale used on Sunrise Medical's Hoyer Presence and Stature Patient Lifts (Cradle), Models: HOY-4pt-WSC and HOY-StatureWSC

    FDA Recall
    Terminated ·Integrated Measurement Systems, Inc.·Product code FRW·January 30, 2007

    BHM Medical Scales, 800 lb. scale weight limit; Part Number 700.00510, Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5; These scales were sold for installation on or as a component of the following patient lifts: a) Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5: Part Number: 88570101, Ergolift 600 BAL. Wide Opening Patient Lift; Part Number : ERGOLIFT-600+SC, Ergolift 600 Lbs with Scale Patient Lift; Part Number: ERGOLIFT-2 + SC, Ergolift 400 Lbs with Scale Patient Lift; b) Manufactured for Sunrise Medical, Longmont, CO 80503: Part Number : 700.05610.06, Hoyer-600 Spreader Bar with Scale; Part Number: 9600102.06, Hoyer-600 Sunrise Patient Lifter with Scale, Model HPL-600WBSC; Part Number: 9600132.06, Hoyer-600 Wide Opening Patient Lifter with Scale

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FRW·December 19, 2007

    SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. Product Usage: The FG3105 Scale is designed for Joerns Healthcare for use in portable patient weighing systems. The scale is designed to be connected between the patient hoist mechanism and patient sling apparatus. The scale is not intended to be used for patient transport.

    FDA Recall
    Terminated ·Sr Instruments Inc·Product code FRW·December 13, 2012

    BHM Medical Scales, 1000 lb. scales weight limit; Part Number 700.00525; Manufactured by BHM Medical Inc., Magog, QC, Canada; These scales were sold for installation on the Model V10 and Model Maxisky fixed ceiling lifts manufactured by BHM Medical.

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FRW·December 19, 2007

    Liko Universal Sling Bar 450 R2R Product NUmber: 3156095

    FDA Recall
    Terminated ·Liko, Inc.·Product code FRW·June 13, 2007

    Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·September 26, 2012

    Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·September 26, 2012

    Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ, LT562-DRW, LT588-DW, LT761-DRW, LT761-DRWZ, LT762-DRW, LT777-DW, LT788-DW, LT961-DRW, LT961-DRWZ, LT962-DRW, LT967-DW, LT977-DW, LT988-DW, TST1763-DRW, TST1764-DRW, TST663-DRW, TST963-DRW, TST964-DRW, VA861-DRW, VA861-DRWZ, VA862-DRW

    FDA Enforcement
    Class II ·Terminated·GN Hearing A/S·December 4, 2019

    Depuy Mitek LUPINE BR W/ORTHCORD Catalog Number: 210711 The Lupine Anchor System is indicated for use in soft tissue bone fixation.

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·January 27, 2012

    Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 14, 2015

    DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)

    FDA Enforcement
    Class II ·Terminated·Neocis, Inc.·February 3, 2021

    DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.

    FDA Enforcement
    Class II ·Terminated·Neocis Inc.·July 22, 2020

    DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.

    FDA Enforcement
    Class II ·Terminated·Neocis Inc.·July 22, 2020

    DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.

    FDA Enforcement
    Class II ·Terminated·Neocis Inc.·July 22, 2020

    Laerdal Compact Suction Unit 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit, 88006201 - LCSU 4, 300 ml, RTCA Complete unit (US), 88006203 - LCSU 4, 300 ml, RTCA Complete unit (UK), 88006240 - LCSU 4, 300 ml, RTCA Complete unit (EUR) and 881152 - Replacement Unit, RTCA; 2) 88005101 - LCSU 4, 800 ml Complete unit (US), 88005103 - LCSU 4, 800 ml Complete unit (UK), 88005140 - LCSU 4, 800 ml Complete unit (EUR), 88005201 - LCSU 4, 800 ml, RTCA Complete unit (US), 88005203 - LCSU 4, 800 ml, RTCA Complete unit (UK), 88005240 - LCSU 4, 800 ml, RTCA Complete unit (EUR) & 2) 800 ml (4.3 lbs) canister version - CATALOG #(s): 88005101, 88005201 (RTCA)

    FDA Recall
    Terminated ·Laerdal Medical Corporation·Product code JCX·January 8, 2017

    Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/; P560K PICC 5FR W/INTRO KIT; MTI451845 4.5FR MINI T/A; MTI551845 5.5FR MINI TA; MTI651845 6.5FR MINI T/A; P460OTW SNGL LUM PICC W/MTI; P4552K DBL LUM PICC INTRO KIT; P5552K DBL LUM PICC INTRO KIT; P4552KOTW DBL LUM OTW PICC INTRO KIT LF; LOCKING T/A INTRODUCERS 11FR; INTRADYN TEAR-AWAY INTRODUCER 4F; INTRADYN TEAR-AWAY INTRODUCER 5F; INTRADYN TEAR-AWAY INTRODUCER 6F; INTRADYN TEAR-AWAY INTRODUCER 7F; INTRADYN TEAR-AWAY INTRODUCER 8F; INTRADYN TEAR-AWAY INTRODUCER 9F; INTRADYN TEAR-AWAY INTRODUCER 10F; INTRADYN TEAR-AWAY INTRODUCER 11F; INTRADYN TEAR-AWAY INTRODUCER 12F; INTRADYN TEAR-AWAY INTRODUCER 15F; INTRADYN TEAR-AWAY INTRODUCER 16F; 23HI120 12F X 23CM HEMO INTRO; 23HI130 13F X 23CM HEMO INTRO; 30STA8 8FR X30CM T/A INTRO -NJ*; 30STA9 9FR X 30CM SHEATH -NJ*; 30STA10 10FR X 30CM T/A INTRO -NJ*; 30STA12 12FR X 30CM T/A INTRO -NJ*; 30STA16 16FR X 30CM SHEATH; BOSTON SCI 16F X 9.54 STEP DIL/SHEATH; 45STA9 45CM T/A INTRODUCER -NJ*; LUTHER 6F - T/A ASSM CLIP; 10HI14038 14F X 11CM HEMO W/WI; BOSTON SCI 12FX 21.35 DIL/SHEATH; 10HI12038 12F X 11CM HEMO W/WI; 10HI13038 13F X 11CM HEMO W/WI; BOSTON SCI 9F X 9.54 STEP DIL/SH; BOSTON SCI 9F X 15.44 STEP DIL/SH; BOSTON SCI 9F X 21.35 STEP DIL/SH; BOSTON SCI 11F X 9.54 STEP DIL/SH; BOSTON SCI 11F X 15.44 STEP DIL/SH; BOSTON SCI 12F X 9.54 DIL/SHEATH; BOSTON SCI 12F X 15.44 DIL/SHEATH; BOSTON SCI 14F X 9.54 DIL/SHEATH; BOSTON SCI 14F X 15.44 DIL/SHEATH; BOSTON SCI 16F X15.44 DIL/SHEATH; 30STA15 15FR LONG TA INTRODUCR; 30STA11 11FR LONG TA INTRODUCR -NJ*; CARDIAC PACEMAKER T/A SHEATH; 14FR TA DILATOR/SHEATH-BULK; 12FR INTRODUCER TEAR AWAY BNS; 12FR TA DIL/SHEATH LC; 8FR TA SHEATH; 10FR TA SHEATH; 16FR TA SHEATH; 8/10FR LOCK T/A INTRO STEPPED; 6FR T/A DILATOR/SHEATH; 6FR LOCKING T/A INTRO ASSY; 14FR X 143MM LOCKING T/A INTRODUCERS; PTFE 4.5 FR BARD ACCESS INTRODUCERS; PTFE 6.0 FR BARD ACCESS INTRODUCERS; 7F LOCKING INTRO SYSTEM; 8 (O/S) FR. LOCKING TEARAWAY INTRODUCER; 9 FR (0/S) LOCKING INTRO SYSTEM; 12F LOCKING INTRO SYSTEM; 14FR LOCKING T/A INTRODUCER; 10FR X 18 CM LOCKING T/A INTRODUCER; 14FR X 12MM LOCKING T/A INTRODUCER; 10.5FR X 18CM LOCKING T/A INTRODUCER; 10FR X 23CM LOCKING T/A INTRODUCER; 10FR LOCKING TEAR-AWAY INTRODUCERS; INTRADYN TEAR-AWAY INTRODUCER 10.5F; 30STA14 14FR X 30CM T/A INTRO -NJ*; BOSTON SCIENTIFIC 15FR LOCKING TEARAWAY; CELSA 5FR LOCKING T/A INTRODUCER; CORDIS 4'' BLUNT TIP T/A SHEATH; MEDTRONIC PS MED INTRO ASM 14F -NJ*; MEDTRONIC PS MED INTRO ASM 15F.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code DYB·May 27, 2005

    Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLX Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code FCW·October 14, 2011