219 results
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7ms
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Sources: EU EUDAMED, US FDA
Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
FDA Enforcement
Class II
·Terminated·Bayer Medical Care, Inc.·September 12, 2018
3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The ceiling stand can be used within a stationary diagnostic X-ray system as well.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 29, 2018
KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant
FDA Enforcement
Class II
·Terminated·Mc-NEIL-PPC, Inc.·October 3, 2012
KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.
FDA Enforcement
Class II
·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013
KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
FDA Enforcement
Class II
·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013
KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
FDA Enforcement
Class II
·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013
Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift Systems Product Usage - The Overhead Rail System allows overhead lifts to be mounted to the ceiling allowing versatility for use in lifting situations. It can be used with different Liko ceiling lifts.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·February 27, 2013
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 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 Angiography systems developed for single and biplane diagnostic imaging
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 8, 2021
Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·November 9, 2016
3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The ceiling stand can be used within a stationary diagnostic X-ray system as well.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 29, 2018
Zero-Gravity Radiation Protection System Radiology Personnel protective shield.
FDA Enforcement
Class II
·Terminated·Contour Fabricators Inc·October 19, 2016
Siemens Artis zee Ceiling Systems. Angiographic x-ray system.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 5, 2014
Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354 Artis Q.zen floor 10848353 Artis zee Biplane 10094141 Artis zee ceiling 10094137 Artis zee floor 10094135 Artis zee floor 10094135 Artis zee multi-purpose 10094139 Artis zeego 10280959
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 21, 2020
Artis zee ceiling, Model Number 10094137
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
Stryker Visum 300 Ceiling-mounted Exam Light.
FDA Enforcement
Class II
·Terminated·Stryker Communications·August 28, 2013
BuckyDiagnost Ceiling System (Stitching Patient Support) 704031
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
FDA Enforcement
Class II
·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·March 2, 2022
Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
FDA Enforcement
Class II
·Terminated·Bayer Medical Care, Inc.·September 12, 2018
AIIuraXperFDlO, System Code 722010 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·October 3, 2018
Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material Number 59880288
FDA Enforcement
Class II
·Terminated·Bayer Medical Care, Inc.·September 12, 2018