27 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Uretero-reno fiberscope URF-P6RP6
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FGB·January 17, 2018
Uretero-reno fiberscope URF-P6
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FGB·January 17, 2018
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·March 8, 2017
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FBN·December 12, 2016
TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China
FDA Recall
Terminated
·Mindray DS USA, Inc. dba Mindray North America·Product code MHX·September 8, 2016
TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. dba Mindray North America·November 9, 2016
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code CEM·April 28, 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
KION Anesthesia System.
FDA Recall
Terminated
·Maquet Inc·Product code BZR·January 11, 2005
CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System; c. CMI-0100-PNX-HS-NO2H, Pro-Nox Hospital System without Oxygen Regulator; d. CMI-0100-PNX-HSWM, Pro-Nox Hospital System Wall Mount with Universal Mount (GCX) scavenger; e. CMI-0100-PNX-NHS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System (Non-hospital); f. CMI-0100-PNX-NHS-PS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System with Passive Scavenger; g. CMI-0100-PNX-US, Pro-Nox mixer, 6' high-pressure O2 and N2O hoses
FDA Recall
Terminated
·CAREstream Medical LLC·Product code BZR·May 15, 2018
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures. Intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code PDR·May 13, 2015
O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
FDA Recall
Terminated
·O-Two Medical Technologies, Inc.·Product code BZR·May 14, 2018
"***REF NL82059-03***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14g, 6"***Plainsboro, NJ***" Needle for lumbar peritoneal shunt
FDA Recall
Terminated
·Integra Neurosciences PR, Inc. Carr·Product code JXG·November 28, 2011
"***REF NL82059-02***INTEGRA NEUROSCIENCES***Suture Collars***Non Sterile for Single Use Only***Plainsboro, NJ***" Collars for lumbar peritoneal shunt
FDA Recall
Terminated
·Integra Neurosciences PR, Inc. Carr·Product code JXG·November 28, 2011
"***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use Only***Size 0.031" OD, Total Length: 8"***Plainsboro, NJ***" Stainless steel stylet for ventricular catheter
FDA Recall
Terminated
·Integra Neurosciences PR, Inc. Carr·Product code JXG·November 28, 2011
"***REF NL86004-01***INTEGRA NEUROSCIENCES***Step Down Connector***Non Sterile for Single Use Only***Small OD .047", Large OD .058"***Plainsboro, NJ***" Step down connector to be secure with ligature
FDA Recall
Terminated
·Integra Neurosciences PR, Inc. Carr·Product code JXG·November 28, 2011
"***REF NL82059-01***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14 g, 3.5"***Plainsboro, NJ***" Needle for lumbar peritoneal shunt
FDA Recall
Terminated
·Integra Neurosciences PR, Inc. Carr·Product code JXG·November 28, 2011
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery
FDA Enforcement
Class II
·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery
FDA Enforcement
Class II
·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012