251 results
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Sources: EU EUDAMED, US FDA
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WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips
FDA Recall
Open, Classified
·Teleflex Medical·Product code FZP·October 4, 2019
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The HawkOne catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature.
FDA Recall
Terminated
·Product code MCW·December 6, 2021
Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas. Hem-o-lok Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures.
FDA Recall
Terminated
·Teleflex Medical·Product code FZP·February 2, 2016
WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips
FDA Recall
Open, Classified
·Teleflex Medical·Product code FZP·October 4, 2019
Weck, Endo5, Hem-o-lok ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use. Weck Closure Systems, TFX Medical Ltd., Halifax Road, P.O. Box 138, High Wycombe HP123NB U.K.
FDA Recall
Terminated
·Product code GDO·October 31, 2001
Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Teleflex Medicals Hem-o-lok polymer ligating clips are single use, sterile, non-absorbable medial devices that have been designed to ligate vessels and tissue structures during various types of surgical procedures. Vessels and tissue structures in the range of 0.5 to 16 mm can be effectively ligated with Hem-o-lok clips.
FDA Recall
Terminated
·Teleflex Medical·Product code FZP·September 25, 2012
Hem-o-lok Endo5 Ligation Applier
FDA Recall
Terminated
·Product code HBT·August 18, 2004
8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000 REF 470230
FDA Recall
Open, Classified
·Intuitive Surgical, Inc.·Product code NAY·December 19, 2024
PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1m average particle size with narrow upper limit particle distribution.
FDA Recall
Terminated
·Ultradent Products, Inc.·Product code EBF·August 31, 2020
Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidations of multiple clinical chemistry and immunoassay analytical instruments into a unified workstation.
FDA Recall
Terminated
·Abbott Laboratories·Product code CEM·April 2, 2020
8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·November 3, 2014
WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO
FDA Recall
Terminated
·Teleflex Medical·Product code FZP·October 5, 2017
Adult ThermoGard Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and return to the electrosurgical generator.
FDA Recall
Terminated
·Conmed Corporation·Product code GEI·May 18, 2016
Pediatric ThermoGard Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used for the dispersion and return to the electrosurgical generator.
FDA Recall
Terminated
·Conmed Corporation·Product code GEI·May 18, 2016
Adult ThermoGard Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310. Intended to be used for the dispersion and return to the electrosurgical generator.
FDA Recall
Terminated
·Conmed Corporation·Product code GEI·May 18, 2016
Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.05m) Cable, Catalog Number 7-382. Intended to be used for the dispersion and return to the electrosurgical generator.
FDA Recall
Terminated
·Conmed Corporation·Product code GEI·May 18, 2016
Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.05m) Cable, Catalog Number 7-383. Intended to be used for the dispersion and return to the electrosurgical generator.
FDA Recall
Terminated
·Conmed Corporation·Product code GEI·May 18, 2016
Hem-o-LokSMX Legating Clip, REF 544220, Lot 988384, Non-absorbable Polymer Ligation Clips, Sterile EO, Weck Closure Systems, Research Triangle Park, NC 27709, Sterile, Single use, Disposable.
FDA Recall
Terminated
·Product code FZP·January 23, 2004
Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
FDA Recall
Terminated
·Remel Inc·Product code JSG·April 17, 2019
Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
FDA Recall
Terminated
·Remel Inc·Product code JSG·April 17, 2019