35 results
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8ms
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Sources: EU EUDAMED, US FDA
Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser.
FDA Enforcement
Class II
·Terminated·Candela Corporation·October 30, 2019
Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser.
FDA Enforcement
Class II
·Terminated·Candela Corporation·October 30, 2019
Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.
FDA Enforcement
Class II
·Terminated·Candela Corporation·October 30, 2019
Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.
FDA Enforcement
Class II
·Terminated·Candela Corporation·October 30, 2019
Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·January 18, 2017
Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·February 15, 2017
Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.
FDA Enforcement
Class II
·Terminated·Nidek Inc·July 9, 2014
Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM Artis FA 05904441; AXIOM Artis MP 05904466; AXIOM Artis BC 05904649; AXIOM Artis BA 05904656; AXIOM Artis dBC Mag. Nav. 05917054; AXIOM Artis TA 07007755; AXIOM Artis dTA 07008605; AXIOM Artis dFC 07412807; AXIOM Artis dTC 07413078; AXIOM Artis dBA 07555357; AXIOM Artis dMP 07555365; AXIOM Artis dFA 07555373; AXIOM Artis dFC Mag. Nav. 07727717; AXIOM Artis TC 07728350; AXIOM Artis dBC 07728392; Artis zee floor 10094135; Artis zee ceiling 10094137; Artis zee MP 10094139; Artis zee biplane 10094141; Artis zee floor MN 10094142; Artis zee biplane MN 10094143; Artis Q floor 10848280; Artis Q ceiling 10848281; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen ceiling 10848354; Artis Q.zen biplane 10848355.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·May 5, 2021
AXIOM Artis dFC, Model Number 7727717
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
AXIOM Artis dFC, Model Number 7412807
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.
FDA Enforcement
Class II
·Terminated·Nidek Inc·September 4, 2013
microTargeting" Drive System, Product Number MT-DS-01
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" Drive System Distributed by Medtronic, Product Number FC1006
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" Drive System, Product Number 66-ZD-MD-01
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018