29 results
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15ms
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Sources: EU EUDAMED, US FDA
Pediatric Craniotome Ref:CRANI-P-G1
FDA Enforcement
Class II
·Ongoing·The Anspach Effort, Inc.·January 18, 2023
NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.
FDA Enforcement
Class II
·Terminated·NOVADAQ TECHNOLOGIES INC.·October 4, 2017
Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery.
FDA Enforcement
Class II
·Terminated·NOVADAQ TECHNOLOGIES INC.·September 14, 2016
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
FDA Enforcement
Class II
·Ongoing·SURGICAL SPECIALTIES·April 24, 2024
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
FDA Enforcement
Class II
·Ongoing·CP Medical Inc·December 18, 2019
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
FDA Enforcement
Class II
·Ongoing·Ethicon, Inc.·May 18, 2022
STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
FDA Enforcement
Class II
·Ongoing·Ethicon, Inc.·November 9, 2022
OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018
OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G
FDA Enforcement
Class II
·Terminated·AROA Biosurgery, LTD.·November 21, 2018