36 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
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 Recall
Terminated
·NOVADAQ TECHNOLOGIES INC.·Product code IZI·August 18, 2016
SHERPA NX ACTIVE GUIDING CATHETER, 6F, PK1, 47CM, 070", REF SA6PK1W. for cardiovascular use
FDA Recall
Terminated
·Medtronic Vascular·Product code DQY·March 15, 2019
C-SECTION PK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
C-SECTION PK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OHM·July 10, 2015
TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER REINFORCED LIF ( 1) CAUTERY TIP POLISHER LIF (8) TOWEL CLOTH HUCK (BLUE) ( 1) BULB SYRINGE 60cc LIF ( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE (2) LITE GLOVE ( 1) TUBE SUCTION CONNECT. Y.." X 12' LIF ( 1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF ( 1) DRAPE % ECONOMY 53" X 77" LIF ( 1) SHEET SPLIT W/ADHESIVE 77" x 146" (2) GOWN XL SMS IMPERVIOUS REINFORCED LIF (2) SYRINGE 60ml WITHOUT NEEDLE LUER LOCK LIF ( 1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF ( 1) STAPLE SKIN 35 WIDE LIF ( 1) TRAY MAYO LARGE (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF ( 1) SOLUTION SURGICAL DURAPREP 26ml LIF ( 1) Pk. NEUROPATTIES 0.45MM 10ea/pk ( 1) Pk. NEUROPATTIES 0.35MM 10ea/pk Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
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 Recall
Terminated
·NOVADAQ TECHNOLOGIES INC.·Product code MMP·June 27, 2017
TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER REINFORCED LIF ( 1) CAUTERY TIP POLISHER LIF (8) TOWEL CLOTH HUCK (BLUE) ( 1) BULB SYRINGE 60cc LIF ( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE (2) LITE GLOVE ( 1) TUBE SUCTION CONNECT. Y.." X 12' LIF ( 1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF ( 1) DRAPE % ECONOMY 53" X 77" LIF ( 1) SHEET SPLIT W/ADHESIVE 77" x 146" (2) GOWN XL SMS IMPERVIOUS REINFORCED LIF (2) SYRINGE 60ml WITHOUT NEEDLE LUER LOCK LIF ( 1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF ( 1) STAPLE SKIN 35 WIDE LIF ( 1) TRAY MAYO LARGE (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF ( 1) SOLUTION SURGICAL DURAPREP 26ml LIF ( 1) Pk. NEUROPATTIES 0.45MM 10ea/pk ( 1) Pk. NEUROPATTIES 0.35MM 10ea/pk Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
Halyard Closed Suction System for Adults, Multi-AccessPortClosedSuctionSystemforAdults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;
FDA Recall
Terminated
·Halyard Health, Inc·Product code BSY·February 7, 2018
Revanesse Versa, PN40081
FDA Recall
Terminated
·Prollenium Medical Technologies Inc.
138 Industrial Pky N
Aurora Canada·Product code LMH·November 15, 2018
Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following: a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE); b. HALYARD* 12 FR TRACH CARE DSE ENDO; c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE); d. HALYARD* 12FR TRACH CARE DSE TRACH; e. HALYARD* 14FR DSE 21.3IN/54CM (GREEN); f. HALYARD* 14FR TRACH CARE DSE ENDO; g. HALYARD* 14FR DSE 12IN/30.5CM (GREEN); h. HALYARD* 14FR TRACH CARE DSE TRACH; i. HALYARD* 14FR DSE 12IN/30.5CM; j. HALYARD* 14FR TRACH CARE WET PAK* DSE MDI TRACH; k. HALYARD* 14FR TRACH CARE WET PAK* DSE ENDO; l. HALYARD* 14FR TRACH CARE WET PAK* DSE DIR TIP ENDO; m. HALYARD* 14 FR TRACH CARE DSE DUAL LUMEN ENDO; n. HALYARD* 14FR TRACH CARE DSE MDI ENDO; o. HALYARD* 14FR DSE 22.2IN/56 CM (GREEN); p. HALYARD* 14FR TRACH CARE DSE DIR TIP ENDO; q. HALYARD* 16FR DSE 21.3IN/54CM (ORANGE); r. HALYARD* 16FR TRACH CARE DSE ENDO; s. HALYARD* 16FR TRACH CARE WET PAK* DSE ENDO
FDA Recall
Terminated
·Halyard Health, Inc·Product code BSY·February 7, 2018
AxSYM CMV IgM Reagent Pack; list 05C78; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories·Product code LKQ·April 23, 2007
Si emans Simiae 3000 Cassette Holder Electronic Imaging device (Image Identifier), with CT Part No: 19 57-161 or without CT Part No. 19 57 153; Siemens Medical Solutions USA, Concord, CA 94520
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code KPQ·February 27, 2007
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
FDA Recall
Terminated
·Medivators, Inc.·Product code FKQ·April 20, 2021
Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77.
FDA Recall
Terminated
·Varian Medical Systems Oncology Systems·Product code KPQ·January 3, 2008
AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPQ·May 24, 2012
Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with CT, Part No: 54 96 984; Siemens Medical Solutions USA, Concord, CA 94520
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code KPQ·February 27, 2007
Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with IDI, Part No: 54 97 016; Siemens Medical Solutions USA, Concord, CA 94520
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code KPQ·February 27, 2007
Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems
FDA Recall
Terminated
·Varian Medical Systems Inc·Product code KPQ·June 25, 2007