1,271 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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8mm FlexDex Needle Driver, Product Code FD-335 ND
FDA Recall
Terminated
·FlexDex Inc.·Product code MDM·December 22, 2021
Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
FDA Recall
Terminated
·Ellipse A/S Agern Alle 11 Horsholm Denmark·Product code GEX·May 5, 2016
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
FDA Recall
Terminated
·Ellipse A/S Agern Alle 11 Horsholm Denmark·Product code GEX·May 5, 2016
Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
FDA Enforcement
Class II
·Terminated·Ellipse A/S·June 15, 2016
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
FDA Enforcement
Class II
·Terminated·Ellipse A/S·June 15, 2016
8mm FlexDex Needle Driver, Product Code FD-335 ND
FDA Enforcement
Class II
·Terminated·FlexDex Inc.·February 2, 2022
8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·November 3, 2014
8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·December 3, 2014
Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
FDA Enforcement
Class II
·Terminated·Leoni Fiber Optics GmbH·December 19, 2018
Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
FDA Enforcement
Class II
·Terminated·Leoni Fiber Optics GmbH·December 19, 2018
Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
FDA Enforcement
Class II
·Terminated·Leoni Fiber Optics GmbH·December 19, 2018
Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
FDA Enforcement
Class II
·Terminated·Leoni Fiber Optics GmbH·December 19, 2018
Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
FDA Enforcement
Class II
·Terminated·Leoni Fiber Optics GmbH·December 19, 2018
SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A304916, A304918, A307414A, A307416A, A319414AM, A319416A, A319416AM, A319418AM, A319514AM, A319516A, A319516AM, A333100A, A333416A, A339414AM, A339516AM, A339516AM, A344916, A800064, A800065, A800364, A800365, A800366, A900216, A900416, A901216, A902114, A902216, A902414, A902416, A902418, A902616, A902914, A902916, A902918, A903314A, A903316A, A903318A, A903416A, A904100, A904400A, A909116M, A909216M, A919416AM, A919516AM, A942206, A942208, A942210, A942212, A942214, A942216, A942218, A942616, A942618, A943214, A943216, A943218, MTA902416 Product Usage catheter
FDA Recall
Terminated
·Bard Medical Division·Product code MJC·December 13, 2018
1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose
FDA Recall
Terminated
·Nephros Inc·Product code ND·October 28, 2013
Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose
FDA Recall
Terminated
·Nephros Inc·Product code ND·October 28, 2013
Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
FDA Enforcement
Class II
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·February 28, 2018
REF 905572, 5.5mm Lactoscrew Anchor,WI Maxbraid No Nd (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN Product Usage: The Biomet Sports Medicine Soft Tissue Anchoring Devices are resorbable repair devices used to attach soft tissue to bone.
FDA Recall
Terminated
·Biomet, Inc.·Product code HWC·January 25, 2012
RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product Usage: Tracheal intubation during laser surgery in the laryngeal area. The tube is resistant to the following kinds of laser: A R+ laser / ND/YAG laser / CO2 lasers (continuous-wave or pulsed) with a wave length ranging from 0.488 ¿m to 10.6 ¿m.
FDA Enforcement
Class II
·Terminated·TELEFLEX MEDICAL INC·July 15, 2020
Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008), b) D 2.7MM X 10MM (002-E-27010); c) D 2.7MM X 12MM (002-E-27012); d) D 2.7MM X 14MM (002-E-27014); e) D 2.7MM X 16MM (002-E-27016); f) D 2.7MM X 18MM (002-E-27018); g) D 2.7MM X 20MM (002-E-27020); h) D 2.7MM X 22MM (002-E-27022); i) D 2.7MM X 24MM (002-E-27024); j) D 2.7MM X 26MM (002-E-27026); k) D 2.7MM X 28MM (002-E-27028); l) D 2.7MM X 30MM (002-E-27030); m) D 2.7MM X 32MM (002-E-27032); n) D 2.7MM X 34MM (002-E-27034); o) D 2.7MM X 36MM (002-E-27036); p) D 2.7MM X 38MM (002-E-27038); q) D 2.7MM X 40MM (002-E-27040)
FDA Recall
Terminated
·Orthofix, Inc·Product code HRS·April 6, 2018