27 results
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57ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.
FDA Recall
Terminated
·Vascular Technology, Inc.·Product code DPW·June 19, 2018
VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
FDA Recall
Terminated
·Vascular Technology, Inc.·Product code DPW·May 28, 2014
07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
FDA Recall
Terminated
·Vascular Technology, Inc.·Product code DPW·May 28, 2014
07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
FDA Recall
Terminated
·Vascular Technology, Inc.·Product code DPW·May 28, 2014
07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
FDA Recall
Terminated
·Vascular Technology, Inc.·Product code DPW·May 28, 2014
Angiotech Vascular Access Needle. A) "Modified Potts/Cournand" Needle. STERILE. Product Number: MPCN1802. 510k K974745. Qty Dist. - 425. B) "Seldinger" Needle. STERILE. Product Number: SN1802, SN1902. 510k K974745. Qty Dist. - 5,250. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Vascular Access Needle
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code DRC·September 1, 2009
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.
FDA Recall
Open, Classified
·Koven Technology, Inc.·Product code DPW·March 4, 2026
GE Healthcare Innova 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.
FDA Recall
Terminated
·Datex Ohmeda, Inc·Product code MQB·August 17, 2006
GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and Vascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.
FDA Recall
Terminated
·Datex Ohmeda, Inc·Product code MQB·August 17, 2006
Angiotech Drainage Cather. SKATER Centesis Cather XFr. STERILE. Product Number: 700304007, 700304010, 700304015, 700305007, 700305010, 7003015. 510k Exempt. Qty Dist. - 4,250. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Drainage Cather
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code JCY·September 1, 2009
Angiotech Galactography Kit. Galactography Kit 30ga with Straight Cannula and Galactography Kit 30ga with Curved Cannula. STERILE. Product Number: DGK002SX, DGK002X. 510k K980227. Qty Dist. - 2,630. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Injection Media Contrast Kit Needle
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code FMI·September 1, 2009
Angiotech Pediatric Bone Marrow Needle. Pediatric Bone Marrow Needle. STERILE. Product Number: ION18015. 510k K980196. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Pediatric Bone Marrow Needle
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009
Angiotech Prostate Stabilization Set. Prostate Stabilization Set. STERILE. Product Number: 500118200. 510k K944522. Qty Dist. - 4,180. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Prostate Stabilization Set
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code IWJ·September 1, 2009
Angiotech Needle Guide. Needle Guide for Lorad Stereo Loc. STERILE. Product Number: LNGC14GX, LNGC1619PX, LNGC2022YX, LNGO1619PX, LNGO2022YX. 510k Exempt. Qty Dist. - 13,800. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Needle Guide
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code GDF·September 1, 2009
GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.
FDA Recall
Terminated
·Datex Ohmeda, Inc·Product code MQB·August 17, 2006
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-220, UPN Product No. M001452200, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-213, UPN Product No. M001452130, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology - (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-362, UPN Product No. M001453620, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Plastic Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-366, UPN Product No. M0 01453660, Sterile, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port With PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-215, UPN Product No. M001452150, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010