49 results
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18ms
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Sources: EU EUDAMED, US FDA
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Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
FDA Enforcement
Class II
·Ongoing·Fujifilm Irvine Scientific, Inc.·April 5, 2023
a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated Dressing Shur-Conform 3 X 8 Inch Knitted Cellulose Acetate Petrolatum Emulsion Sterile Model Number: 77042. b. INTEGRA LIFESCIENCE (WND CARE) ALGICELL Ag Silver Alginate Dressing Algicell Ag 4 X 5 Inch Rectangle Sterile Model Number: DUP88545
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·March 23, 2016
Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stretcher
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·March 23, 2016
Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
FDA Enforcement
Class II
·Terminated·Rainbow Specialty & Health Products·December 30, 2015
Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044), Integris-Allura 9 (722018), Integris-Allura 9 (Biplane) (722021), Integris CV Cesar-Powerpack (722030), Integris H5000 C / Allura 9C (722016);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".
FDA Enforcement
Class II
·Terminated·Philips And Neusoft Medical Systems Co., Ltd.·August 1, 2012
MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·September 26, 2012
Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR LF (12 MGM61 61- Catalog #61-59120. b. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/2"X5YDSSTR LF (12/CS) MGM61 Catalog #61-59220. c. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1"X5YDS STR LF (12/CS) MGM61 Catalog #61-59320. d. DERMA SCIENCES, INC. MediHoney DRESSING, MEDIHONEY GEL STR TU0.5OZ (10/BX 4BX/CS) MGM61 Catalog #DUP31805. e. DERMA SCIENCES, INC DuPad PAD, ABD STR 8X10 (25/BX 8BX/CS) Catalog #DUP87810. f. DERMA SCIENCES, INC Shur-Conform Oil Emulsion non-adhering DRESSING, OIL EMULSION 3"X3"23251-210 DERSCI Catalog #DKC77041
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
FDA Enforcement
Class II
·Terminated·Cooper Vision Caribbean Corp.·January 9, 2013
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
FDA Enforcement
Class II
·Ongoing·KOB GmbH·March 18, 2026
GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 8, 2013
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.
FDA Enforcement
Class I
·Terminated·Codman & Shurtleff, Inc.·January 29, 2014
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
FDA Enforcement
Class II
·Ongoing·Abiomed, Inc.·July 19, 2023
Brilliance Big Bore Radiology 728244
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 4, 2018
Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·January 4, 2017
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 3, 2025
Ingenuity TF PET/CT 882442
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 4, 2018
Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
FDA Enforcement
Class II
·Terminated·Shimadzu Medical Systems·January 4, 2017
Philips Ingenuity Core 728321
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 4, 2018