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Sources: EU EUDAMED, US FDA
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The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures).
FDA Enforcement
Class II
·Terminated·Peters Surgical·October 1, 2014
The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOFLON Evolution sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures).
FDA Enforcement
Class II
·Terminated·Peters Surgical·October 1, 2014
E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek¿ - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.
FDA Enforcement
Class II
·Terminated·Megadyne Medical Products, Inc.·September 4, 2013
TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is provided to the patient, depending on the therapy objective.
FDA Enforcement
Class II
·Terminated·Tec Com Gmbh·November 20, 2019
Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused.
FDA Enforcement
Class II
·Terminated·Megadyne Medical Products, Inc.·March 19, 2014
D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code HWC·March 7, 2018
Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.
FDA Recall
Terminated
·SPS Sterilization, Inc·Product code DWF·March 7, 2018
Vascular Solutions Venture Rx Catheter, 6F, resterilized.
FDA Recall
Terminated
·SPS Sterilization, Inc·Product code DQY·March 7, 2018
Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
FDA Recall
Terminated
·SPS Sterilization, Inc·Product code DWF·March 7, 2018
Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized.
FDA Recall
Terminated
·SPS Sterilization, Inc·Product code JCT·March 7, 2018
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
FDA Recall
Terminated
·SPS Sterilization, Inc·Product code DWF·March 7, 2018
Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
FDA Recall
Terminated
·SPS Sterilization, Inc·Product code MQR·March 7, 2018
Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized.
FDA Recall
Terminated
·SPS Sterilization, Inc·Product code DWF·March 7, 2018
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized.
FDA Recall
Terminated
·SPS Sterilization, Inc·Product code JCT·March 7, 2018
Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.
FDA Recall
Terminated
·SPS Sterilization, Inc·Product code DWF·March 7, 2018
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
FDA Recall
Terminated
·SPS Sterilization, Inc·Product code DWF·March 7, 2018
Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.
FDA Recall
Terminated
·SPS Sterilization, Inc·Product code DQR·March 7, 2018
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L, resterilized.
FDA Recall
Terminated
·SPS Sterilization, Inc·Product code JCT·March 7, 2018
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.
FDA Recall
Terminated
·SPS Sterilization, Inc·Product code JCT·March 7, 2018
Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized.
FDA Recall
Terminated
·SPS Sterilization, Inc·Product code JCT·March 7, 2018