136 results · 20ms · Sources: EU EUDAMED, US FDA

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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

JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;

FDA Enforcement
Class II ·Terminated·Carefusion 2200 Inc·April 25, 2018

JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;

FDA Enforcement
Class II ·Terminated·Carefusion 2200 Inc·April 25, 2018

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

JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;

FDA Recall
Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;

FDA Recall
Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

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

Monoject Bone Marrow Biopsy / Aspiration Tray with Safety Components 8G x 4 inch Product Number: 8881847084

FDA Recall
Terminated ·Kendall Healthcare Products Co·Product code FMI·October 8, 2004

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

T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimens

FDA Enforcement
Class II ·Terminated·Argon Medical Devices, Inc·February 22, 2017

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