34 results
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42ms
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Sources: EU EUDAMED, US FDA
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Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek¿/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·October 7, 2015
Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Component: N/A
FDA Enforcement
Class II
·Ongoing·Sterilmed, Inc.·November 26, 2025
Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324
FDA Enforcement
Class II
·Terminated·Sterilmed, Inc.·October 17, 2018
Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·October 15, 2014
Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and equipment out of reach or they interface an EP catheter with the appropriate external stimulation of recording equipment.
FDA Enforcement
Class II
·Terminated·Sterilmed Inc·July 12, 2017
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015
St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
FDA Enforcement
Class I
·Terminated·Sterilmed Inc·January 3, 2018
Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·June 8, 2016
Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Component: N/A
FDA Enforcement
Class II
·Ongoing·Sterilmed, Inc.·November 26, 2025
Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No
FDA Enforcement
Class II
·Ongoing·Trinity Sterile, Inc.·January 29, 2025
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Component: No
FDA Enforcement
Class II
·Ongoing·Trinity Sterile, Inc.·January 29, 2025
Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
FDA Enforcement
Class II
·Terminated·Trinity Sterile, Inc.·August 24, 2022
Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF
FDA Enforcement
Class II
·Terminated·Trinity Sterile, Inc.·August 24, 2022
Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
FDA Enforcement
Class II
·Terminated·Trinity Sterile, Inc.·August 24, 2022
Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
FDA Enforcement
Class II
·Terminated·Trinity Sterile, Inc.·August 24, 2022
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
FDA Enforcement
Class II
·Terminated·SPS Sterilization, Inc·September 19, 2018
Vascular Solutions Venture Rx Catheter, 6F, resterilized.
FDA Enforcement
Class II
·Terminated·SPS Sterilization, Inc·September 19, 2018
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L, resterilized.
FDA Enforcement
Class II
·Terminated·SPS Sterilization, Inc·September 19, 2018
Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.
FDA Enforcement
Class II
·Terminated·SPS Sterilization, Inc·September 19, 2018
Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.
FDA Enforcement
Class II
·Terminated·SPS Sterilization, Inc·September 19, 2018