BEUDAMED
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    Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental procedures.

    FDA Enforcement
    Class II ·Terminated·Pelton & Crane / Marus / DCI Equipment / KaVo·April 6, 2016

    Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental procedures.

    FDA Recall
    Terminated ·Pelton & Crane Marus DCI Equipment KaVo·Product code EAZ·March 8, 2016

    GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS MEDICAL LIMITED, FORTRAN ROAD, ST. MELLONS, CARDIFF, CF3 0LT, UK

    FDA Recall
    Terminated ·Gyrus Acmi, Incorporated·Product code GEI·August 6, 2010

    LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED L/F (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TUR Y SET, 2LEAD L/F (4) DRAPE UTILITY WITH TAPE LIF (1) TROCAR ENDO. XCEL DILATING TIP 5mm (K5LT) (1) ULTRA VERES NEEDLE 120mm (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (1) DRAPE LAP. ABDOM. WITH POUCH 102" X 122" X 78" (2) DRAPE SHEET 41" X 58" SMS (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD L/F (5) LAP SPONGE PREWASH XRD LIF (1 ) DRAPE LASER CAMERA W/EL. 6" X 96" LIF (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) TROCAR ENDOPATH XCEL DILATING TIP 11mm (K1 1LT) (1) TUBING INSUFLATION SET W/0 RING ADAPTOR LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) TABLE COVER REINFORCED 50" X 90" 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

    LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED L/F (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TUR Y SET, 2LEAD L/F (4) DRAPE UTILITY WITH TAPE LIF (1) TROCAR ENDO. XCEL DILATING TIP 5mm (K5LT) (1) ULTRA VERES NEEDLE 120mm (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (1) DRAPE LAP. ABDOM. WITH POUCH 102" X 122" X 78" (2) DRAPE SHEET 41" X 58" SMS (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD L/F (5) LAP SPONGE PREWASH XRD LIF (1 ) DRAPE LASER CAMERA W/EL. 6" X 96" LIF (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) TROCAR ENDOPATH XCEL DILATING TIP 11mm (K1 1LT) (1) TUBING INSUFLATION SET W/0 RING ADAPTOR LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) TABLE COVER REINFORCED 50" X 90" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code FDE·May 20, 2014

    Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile

    FDA Recall
    Terminated ·QLT USA, Inc.·Product code LYC·January 26, 2006

    MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.

    FDA Enforcement
    Class II ·Terminated·Med-Hot Thermal Imaging, Inc.·May 17, 2017

    MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.

    FDA Recall
    Terminated ·Med-Hot Thermal Imaging, Inc.·Product code LHQ·January 14, 2017

    GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT N-K FLX GSM POR FEM SZ 5 LT N-K FLX GSM POR FEM SZ 5 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)

    FDA Recall
    Terminated ·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code HSB·September 18, 2020

    OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)

    FDA Recall
    Terminated ·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code HSB·September 18, 2020

    Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only

    FDA Recall
    Terminated ·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code JDR·January 18, 2022

    OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)

    FDA Recall
    Terminated ·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code HSB·September 18, 2020

    OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails

    FDA Recall
    Terminated ·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code HSB·September 18, 2020

    Ref. No. 523171 Hemoclip, 10 Large Tantalum Clips/Cartridge (Non-Sterile) and Ref. No. 523371 Hemoclip, 15 Large Tantalum Clips/Cartridge (Non-Sterile)

    FDA Recall
    Terminated ·Product code HBT·October 24, 2003

    Ref No. 523470 Hemoclip, 15 Large Stainless Steel Clips/Cartridge and Ref. No. 523670 Hemoclip, 10 Large Stainless Steel Clips/Cartridge

    FDA Recall
    Terminated ·Product code HBT·October 24, 2003

    Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code HET·June 25, 2008

    (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; (c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Storz Scope, Catalog #88-9808; and (d) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Wolf Scope, Catalog #88-9809.

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code HET·February 23, 2022

    Gynecare Morcellex Tissue Morcellator; Manufactured by: Ethicon Women's Health & Urology; A Division of ETHICON INC, a Johnson & Johnson Company, Somerville, NJ 08876

    FDA Recall
    Terminated ·Ethicon, Inc. US·Product code HET·September 28, 2009

    Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code HET·June 25, 2008