44 results
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11ms
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Sources: EU EUDAMED, US FDA
Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC Part 15 Class A. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA 94089 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
FDA Enforcement
Class II
·Terminated·Optimedica Corporation·January 15, 2014
Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler
FDA Enforcement
Class II
·Terminated·Surgical Tissue Network, Inc.·January 16, 2013
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·June 5, 2019
Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
FDA Enforcement
Class II
·Terminated·Westmed Inc·October 31, 2012
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
FDA Enforcement
Class II
·Terminated·Westmed Inc·October 31, 2012
Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175
FDA Enforcement
Class I
·Terminated·Applied Medical Resources Corp·May 13, 2020
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, w/Crickett 25g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
FDA Enforcement
Class II
·Terminated·Westmed Inc·October 31, 2012
Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-14. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
FDA Enforcement
Class II
·Terminated·Westmed Inc·October 31, 2012
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
microTargeting" Drive System, Product Number 66-ZD-MD
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018