39 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reactions. LATEX FREE , CAUTION: FEDERAL lAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Single Use Only bands items together and podiatry office uses bands as tourniquet on toe during in grown toenail procedure

FDA Recall
Terminated ·Centurion Medical Products Corporation·Product code LDQ·October 28, 2013

Acacia Catalog # 385166 Dual "Y" IV Extension Set 50cm Macro Bore, Spin Nut w/BD Q-Syte

FDA Recall
Terminated ·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009

Acacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte

FDA Recall
Terminated ·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009

Acacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte

FDA Recall
Terminated ·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009

Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte

FDA Recall
Terminated ·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009

Acacia Catalog # 385165 "Y" IV Extension Set 20cm Macro Bore, Spin Nut w/BD Q-Syte

FDA Recall
Terminated ·Medical Product Specialist Inc dba MPS Acacia·Product code FPA·December 18, 2009

MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151

FDA Recall
Terminated ·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009

MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164

FDA Recall
Terminated ·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009

BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy Systems Inc.

FDA Recall
Terminated ·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009

BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Instaflash Needle Technology; Rx Only, Sterile EO. BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon" catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, dual port adapter, vent plug and pre-attached BD Q-Syte Luer Access Split Septum. The needle and catheter are protected by a needle cover. A BD Q-Syte device or an end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices have BD Instaflash" Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and dual port adapter are color coded to indicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green). BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.

FDA Recall
Open, Classified ·Becton Dickinson Infusion Therapy Systems Inc.·Product code FOZ·September 8, 2021

BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therapy Systems Inc.

FDA Recall
Terminated ·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009

BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102, Becton Dickinson Infusion Therapy Systems Inc.

FDA Recall
Terminated ·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009

Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.

FDA Recall
Terminated ·Medical Action Industries Inc·Product code FPA·November 6, 2009

Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum (BD #385100)), Part number: 69498.

FDA Recall
Terminated ·Medical Action Industries Inc·Product code FPA·November 6, 2009

Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B.

FDA Recall
Terminated ·Medical Action Industries Inc·Product code FPA·November 6, 2009

BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, REF 385101, Becton Dickinson Infusion Therapy Systems Inc.

FDA Recall
Terminated ·Becton Dickinson Medical Systems·Product code FPA·October 19, 2009

ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.

FDA Recall
Terminated ·LDR Spine USA, Inc.·Product code LXH·August 29, 2016

BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.

FDA Recall
Terminated ·Becton Dickinson & Company·Product code FPA·February 19, 2015

Kinamed SuperCable Grip and Plate System Driver, 3.5mm Hex, Catalog Number: 35-860-2060 The driver is intended to be used in conjunction with compression and locking bone screws for fixation of long bone fractures when Kinamed Trochanteric Grips & Cable-Plates are used. Subsequent Product Codes: HWC, JDQ.

FDA Recall
Terminated ·Kinamed Inc·Product code KTT·August 18, 2010

Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDQ·February 16, 2016