BEUDAMED
    29 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces. The instrument is introduced via percutaneous cut when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 6, 2016

    Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·September 3, 2013

    Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products Inc·September 25, 2013

    Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

    FDA Recall
    Terminated ·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015

    TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

    FDA Recall
    Terminated ·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015

    MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

    FDA Recall
    Terminated ·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015

    TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Component 7LR (5/pk), TS ROC Crown Component 8LR (5/pk), TS ROC Crown Component 4UL (5/pk), TS ROC Crown Component 5UL (5/pk), TS ROC Crown Component 6UL (5/pk), TS ROC Crown Component 7UL (5/pk), TS ROC Crown Component 8UL (5/pk), TS ROC Crown Component 4LL (5/pk), TS ROC Crown Component 5LL (5/pk), TS ROC Crown Component 6LL (5/pk), TS ROC Crown Component 7LL (5/pk), TS ROC Crown Component 8LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

    FDA Recall
    Terminated ·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015

    TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk), TS Crown Component 5LL (5/pk), and TS Crown Component 6LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance

    FDA Recall
    Terminated ·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015

    LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

    FDA Recall
    Terminated ·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015

    Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

    FDA Recall
    Terminated ·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015

    M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance

    FDA Recall
    Terminated ·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015

    Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScope Mech. Set Size 24 A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

    FDA Recall
    Terminated ·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015

    HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24 A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

    FDA Recall
    Terminated ·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015

    Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).

    FDA Recall
    Terminated ·Lumenis Ltd 13 Hayetzira St.,Yokneam Ind. Park Yokneam Israel·Product code GEX·November 17, 2015

    ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and; for laser assisted lipolysis

    FDA Recall
    Terminated ·New Star Lasers, Inc.·Product code GEX·September 19, 2016

    CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne vulgaris; For back acne and atrophic scarring, and; For podiatry, (incision, excision, and coagulation of soft tissue), including. matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas

    FDA Recall
    Terminated ·New Star Lasers, Inc.·Product code GEX·September 19, 2016

    Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).

    FDA Enforcement
    Class II ·Terminated·Lumenis Ltd·May 25, 2016

    ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and; for laser assisted lipolysis

    FDA Enforcement
    Class II ·Terminated·New Star Lasers, Inc.·October 12, 2016

    CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne vulgaris; For back acne and atrophic scarring, and; For podiatry, (incision, excision, and coagulation of soft tissue), including. matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas

    FDA Enforcement
    Class II ·Terminated·New Star Lasers, Inc.·October 12, 2016

    EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) GOBAN SELF-ADHERENT WRAP 6" X 5yds (3) BANDAGE ELASTIC 4" X 5yds (1) BANDAGE ESMARK 6" X 9 (1) UTILITY BOWL QUART 32oz (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECTX 12' (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (3) SCALPEL WITH HANDLE# 15 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN (1) LIGHT SHIELD (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR (1) U-DRAPE 60"X 70" WITH TAPE SPLIT 6" X 21" (1) NEEDLE SPINAL ANESTH 18G X 3% (3) GOWN X-LARGE IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (4) DR APE UTILITY WITH TAPE (6) TOWEL ABSORBENT 15" X 20" (3) DRAPE % ECONOMY 53" X 77" (1) YANKAUER OPEN TIP CLEAR W/0 CN (1) CAUTERY TIP POLISHER (1) SUTURE BAG FLORAL (1) GOWN SURG REINFORCED X-LARGE TOWEL & WRAP (1) MERLING SKIN PREP APPLICATOR 39ML (1) SHEET HAND 146" X 104" X 91" (1) TABLE COVER REINFORCED 50" X 90" 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