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Sources: EU EUDAMED, US FDA
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Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
FDA Recall
Terminated
·United Surgical Associates·Product code ITQ·April 13, 2015
Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
FDA Recall
Terminated
·United Surgical Associates·Product code IQI·April 13, 2015
Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
FDA Recall
Terminated
·United Surgical Associates·Product code ITW·April 13, 2015
VenaCureEVLT Perforator Vein Ablation Kit, CATALOG #: EVLT/PVAK, STERILE -- Manufactured for: AngioDynamics Inc. 603 Queensbury, NY 12804 USA, AngioDynamics UK Limited, Building 2000, Beach Drive, IQ Cambridge, Waterbeach, Cambridge, CB259TE, United Kingdom --- COMMON/USUAL NAME: Laser Surgical Instrument; CLASSIFICATION NAME: Powered Laser Surgical Instrument; DEVICE LISTING # D053485. --- Product Usage: The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Diomed D15 plus and D30 plus and EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code GEX·December 6, 2011
Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3L
FDA Recall
Completed
·Covidien Llc·Product code GDW·November 23, 2020
CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.
FDA Recall
Terminated
·Product code GEH·November 10, 2014
daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·May 14, 2007
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
FDA Recall
Terminated
·Product code OVE·September 8, 2021
LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO, Manufactured for Valleylab, a division of Tyco Healthcare Group LP, Boulder, CO. Manufactured by Covidien Medical Products (Shanghai) Manufacturing LLC, Building No. 10, 789 Puxing Road, Shanghai 201114, P.R. Chin., Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics, and tissue bundles.
FDA Recall
Terminated
·Covidien, PLC·Product code GEI·November 4, 2011
LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider, LS1520, Sterile EO, Manufactured for Valleylab a division of Tyco Healthcare Group LP, Boulder, CO 80301, Manufactured by Covidien Medical Products (Shanghai) Manufacturing LLC, Building No. 10, 789 Puxing Rd., Shanghai 201114, P.R. China. Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics, and tissue bundles.
FDA Recall
Terminated
·Covidien, PLC·Product code GEI·November 4, 2011
Gebauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The product consists of a can, a valve and an actuator. Gebauer's Fluro-Ethyl is a vapocoolant (skin refrigerant), topical anesthetic intended to control the pain associated with minor surgical procedures, dermabrasion and injection. It is also effective in providing temporary relief from the pain associated with minor sports injuries.
FDA Recall
Terminated
·Gebauer Company·Product code MLY·September 3, 2008
Everest MI XT Outer Dilator, Catalog Number 5101-90168
FDA Recall
Open, Classified
·Product code KWP·January 13, 2022
Everest MI XT Inner Dilator, Catalog Number 5101-90167
FDA Recall
Open, Classified
·Product code KWP·January 13, 2022
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
FDA Recall
Open, Classified
·O & M HALYARD, INC.·Product code FXX·November 8, 2024
Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S
FDA Recall
Completed
·Covidien Llc·Product code GDW·November 23, 2020
HeartWare HVAD Pump Implant Kit, REF 1104
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Implant Kit, REF MCS1705PU
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Pump Accessories, REF MCS1753AK
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Outflow Graft, REF MCS1725OG
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Pump Implant Kit, REF 1103
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021