187 results
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19ms
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Sources: EU EUDAMED, US FDA
Buzzaround XL scooters' Product Usage: mobility
FDA Enforcement
Class II
·Terminated·Golden Technologies, Inc.·March 26, 2014
Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.
FDA Enforcement
Class II
·Terminated·RF Technologies, Inc.·July 3, 2013
Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
FDA Enforcement
Class II
·Terminated·Apheresis Technologies, Inc.·August 15, 2012
WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
FDA Enforcement
Class II
·Terminated·Biolase Technology Inc·August 27, 2014
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
FDA Enforcement
Class II
·Terminated·Circulatory Technology Inc·July 6, 2016
ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.
FDA Enforcement
Class II
·Terminated·Alung Technologies Inc·February 10, 2021
IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms
FDA Enforcement
Class II
·Terminated·IDEV Technologies, Inc.·June 26, 2013
Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.
FDA Enforcement
Class II
·Terminated·Aperio Technologies Inc·June 26, 2013
Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures.
FDA Enforcement
Class II
·Terminated·MCKESSON TECHNOLOGIES INC·September 4, 2013
AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
FDA Enforcement
Class II
·Terminated·Northgate Technologies, Inc.·June 15, 2022
07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
FDA Enforcement
Class II
·Terminated·Vascular Technology, Inc.·July 16, 2014
07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
FDA Enforcement
Class II
·Terminated·Vascular Technology, Inc.·July 16, 2014
07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
FDA Enforcement
Class II
·Terminated·Vascular Technology, Inc.·July 16, 2014
VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
FDA Enforcement
Class II
·Terminated·Vascular Technology, Inc.·July 16, 2014
SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension.
FDA Enforcement
Class II
·Terminated·Separation Technology, Inc.·May 29, 2013
Xoran MiniCAT00202
FDA Enforcement
Class II
·Terminated·Xoran Technologies, Inc.·November 6, 2013
Xoran MiniCAT CT Scanner
FDA Enforcement
Class II
·Terminated·Xoran Technologies, Inc.·November 6, 2013
Xoran Minicat00202
FDA Enforcement
Class II
·Terminated·Xoran Technologies, Inc.·November 6, 2013
Xoran MiniCAT CT Scanner ID ENT00001
FDA Enforcement
Class II
·Terminated·Xoran Technologies, Inc.·November 6, 2013
Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.
FDA Enforcement
Class II
·Terminated·Synvasive Technology Inc·April 24, 2013