89 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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AccuGuide Injection Needles (Surface electrodes) The AccuGuide EMG Injection Needle, product 8263210, contains 5 individually packaged and sterilized injection needles and 10 nonsterile surface electrodes that are packaged 2 per non-breathable pouch, but are not sterilized.
FDA Recall
Terminated
·Medtronic Xomed, Inc.·Product code GZX·January 22, 2007
Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape, a polylined drape, three gauze pads, and one spot bandage.
FDA Enforcement
Class II
·Terminated·Utah Medical Products, Inc·November 18, 2015
GCX Mountable Downloader-Recharger; (accessory to the i-STAT Portable Clinical Analyzer (model 300). The GCX Mountable Downloader-Recharger (GCX) is a connectivity component that is intended to be mounted to a GCX compatible mount or "arm" and provide a data connection to an authorized manufacturer's patient monitoring systems.
FDA Recall
Terminated
·Abbott Point of Care Inc.·Product code CGA·August 20, 2010
Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·May 28, 2014
StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (Model 0250070520) STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
FDA Enforcement
Class II
·Terminated·Stryker Corporation·March 14, 2018
Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c).
FDA Recall
Terminated
·Cholestech Corp·Product code LCP·August 3, 2006
***REF VP6528***Qty 1***Articulating Arm, Secondary Flat Panel***RX Only***See Instructions for Use***CONMED LINVATEC, CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA*** Catalog No Product VPN6528 Articulating Arm, Secondary Flat Panel. 690-0024-00 Arm, Wall Mount, Flat Screen, GCX For mounting and positioning of flat screen monitors.
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code KQM·September 17, 2010
HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in part:"***Pouch label***HAEMACURE***HemaSyst***tm***Contents: One ***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604*** CE 0297***LOT 111144***2014/10***40680b/20004-02***CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a licensed physician (or properly licensed practitioner).***Contents of unopened undamaged package are sterile***CE 0297***Manufactured by: ***Micromedics*** St. Paul, MN 55121-1385 USA***Distributed by:***Haemacure Corporation***Sarasota, FL 34236 USA***Toll Free 1-877-872-4583***www.haemacure.com***Box label***Contents: 5 packages of 1 each***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604***CE 0297***STERILE EO***LOT 11144***2014/10***40681B/20544***". Sterile, single-use instrument for the application of two liquids.
FDA Recall
Terminated
·Haemacure Corporation·Product code KYZ·November 16, 2009
COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile
FDA Enforcement
Class II
·Terminated·Epimed International·November 15, 2017
PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.
FDA Enforcement
Class I
·Terminated·Tytek Medical Inc·February 19, 2020
Arrow central venous catheterization kit, 14 ga x 20 cm
FDA Recall
Terminated
·Arrow International Inc·Product code KZH·September 16, 2003
Arterial Catheterization Set
FDA Recall
Terminated
·Arrow International Inc·Product code DQX·July 29, 2010
Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.
FDA Enforcement
Class II
·Terminated·Medisystems a NX Stage Company·January 30, 2013
Femoral Artery Catheterization Set
FDA Recall
Terminated
·Arrow International Inc·Product code DQX·July 29, 2010
Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use: Ethylene Oxide sterilized. Remington Medical, Inc., Alpharetta, GA 30005.
FDA Recall
Terminated
·Remington Medical Inc.·Product code KNW·February 15, 2005
Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter
FDA Recall
Terminated
·Arrow International Inc·Product code FOZ·July 29, 2010
Multi-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter (Sharps Safety Features)
FDA Recall
Terminated
·Arrow International Inc·Product code DQY·July 29, 2010
Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter (Sharps Safety Features)
FDA Recall
Terminated
·Arrow International Inc·Product code DQY·July 29, 2010
Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue Catheter
FDA Recall
Terminated
·Arrow International Inc·Product code DQY·July 29, 2010
CE17TKFMHDT 17 GA X 4 FULL EPID KIT, Material Number 332096 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·October 10, 2018