43 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059).
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·May 17, 2017
Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121 Use to make an incision in the tympanic membrane.
FDA Enforcement
Class II
·Terminated·Summit Medical, Inc.·May 22, 2013
Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a clear, sealed bag printed with the part number, 100 filters/box, for single patient use, latex free, box of 100 Reorder Numbers: 5553100 (single filter reorder no. 5553000), 5554100 (single filter reorder no. 5554000), 5555100 (single filter reorder no. 5555000), 5559100 (single filter reorder no. 5559000), 7773100 (single filter reorder no. 7773000), and 7774100 (single filter reorder no. 7774000). The firm name on the label is Alliance Tech Medical, Inc., Granbury, TX, manufactured in Taiwan.
FDA Enforcement
Class II
·Completed·Alliance Tech Medical, Inc·December 25, 2019
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
FDA Enforcement
Class II
·Terminated·B Braun Medical, Inc.·September 18, 2013
VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·October 30, 2013
TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·March 12, 2014
Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
FDA Enforcement
Class II
·Terminated·Vygon Corporation·June 20, 2012
Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
FDA Enforcement
Class II
·Terminated·Vygon Corporation·June 20, 2012
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
FDA Enforcement
Class II
·Terminated·Vygon Corporation·June 20, 2012
Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens
FDA Enforcement
Class II
·Terminated·Vygon Corporation·June 20, 2012
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
FDA Enforcement
Class II
·Terminated·Vygon Corporation·June 20, 2012
Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
FDA Enforcement
Class II
·Terminated·Vygon Corporation·June 20, 2012
Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
FDA Enforcement
Class II
·Terminated·Vygon Corporation·June 20, 2012
Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018
Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018
Contiplex Nerve Block Tray. Product Catalog Number: 570205. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018
Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018
PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018
Pencan Spinal Needle Tray. Product Catalog Number: 333865. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018
Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018