274 results
·
49ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines.
FDA Enforcement
Class II
·Terminated·A M Systems Inc·October 24, 2018
ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between patients For use on all patient populations in conjunction with other respiratory devices containing standard 15mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concern. Disposable, for single patient use only.
FDA Recall
Terminated
·A M Systems Inc·Product code CAH·March 31, 2010
Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines.
FDA Recall
Terminated
·A M Systems Inc·Product code BYX·August 10, 2018
BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441. Stingray" Catheters are intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention. When used as part of the BridgePoint Medical System, the Stingray Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention. .
FDA Enforcement
Class II
·Terminated·Bridgepoint Medical·August 1, 2012
CATH LAB KIT FOR BAPTIST M. C., Item No. 46078-52 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·November 23, 2016
Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256. Intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.
FDA Recall
Terminated
·Orthohelix Surgical Designs Inc·Product code HWC·March 23, 2010
Vertical Brake Hubs of the Computed Tomography X-Ray Systems under the following Brands and Model #s: Brilliance 6, M/Ns 3001-3708, 30001-30131; Brilliance 10, M/Ns 4001-4067, 40001-40035 ; Brilliance 16, M/Ns 5001-6180, 50002-50139 ; Brilliance 16P, M/Ns 6007-6163, 60001-60029 ; Brilliance 40, M/Ns 9009-9272, 29001-29153, 90028-92034; Brilliance 64, M/Ns 9501-10300, 95003-95697; Brilliance Big Bore, M/Ns 7001-7520; Brilliance iCT, M/Ns 100003-100169 & Brilliance iCT SP, M/Ns 200004-200034. The Brilliance Computed Tomography X-Ray Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·December 10, 2010
Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit", "Xenon Circuit", and Needleless Xenon Diagnostic Circuit" Manufactured for RAF MEDICAL, INC., (Model number's RAF2306, RAF2304, RAF2380, RAF2300, RAF2370, RAF2372, RAF2350, RAF2341, RAF2302, RAF2340 RAF2306, RAF2304, RAF2361), or Medico-Mart, Inc. ("Xenon Curcuit" Model number's 2304, 2306). Xenon Diagnostic Circuit Kit: Used in specific Nuclear Medicine Procedures. ViroMax: For use on all patient populations, in conjunction with other respiratory devices containing standard 15 mm and/or 22 mm fittings (such as breathing circuits and the like) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.
FDA Recall
Terminated
·Continental Medical Labs, Inc·Product code CAH·April 16, 2010
Sterile Bone Cutting Burrs model M-6P labeled in part:***M-6P***QTY: 1***6 mm x 9 mm Fluted Pear.***Use with*** MEDIUM Attachments.***Use by 2015-12***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT D493042603***. Cutting and Shaping bone including bones of the spine and cranium.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBC·May 9, 2011
Sterile Bone Cutting Burrs model IMRI-S-8NS-M labeled in part:***IMRI-S-8NS-M***QTY: 1***3 mm Fluted Matchstick, Extends 8.9 mm,***Less Aggressive. Use with IMRI-SHORT***Attachments.***Use by 2014 08***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT C323023789***. Cutting and Shaping bone including bones of the spine and cranium.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBC·May 9, 2011
SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer... SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021". The TEE/8-3 MHz Transducer is designed for 2D, M Mode, color Doppler, pulse wave (PW) Doppler and continuous wave (CW) Doppler by applying ultrasound energy through the esophagus or stomach of the patient into the heart. The TEE transducer is intended to be used on adults only. Backscattered ultrasound energy from the patient's heart is used to form images of the heart to detect abnormalities in structure or motion, to evaluate the velocity of blood flowing within the heart, and to obtain a color depiction of the velocities of blood flowing in the heart.
FDA Recall
Terminated
·Sonosite, Inc.·Product code IYO·August 8, 2008
6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave Clear, NanoClave T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FMG·February 5, 2018
6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FMG·February 5, 2018
5" (13 cm) Smallbore Ext Set w/MicroClave, Clave T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FMG·February 5, 2018
14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FMG·February 5, 2018
7" Ext Set w/MicroClave, Clave T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FMG·February 5, 2018
7" Smallbore Ext Set w/MicroClave, Clave T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FMG·February 5, 2018
Sterile Bone Cutting Burrs model S-5B-4 labeled in part:***S-5B-4***QTY: 1***5 mm Fluted Ball, 4-Series.***Use with***SHORT Attachments.***Use by 2016-03***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT E173049623***. Cutting and Shaping bone including bones of the spine and cranium.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBC·May 9, 2011
Sterile Bone Cutting Burrs model QD8-4OVD labeled in part:***QD8-4OVD***QTY: 1***4 mm x 8 mm Diamond Oval. Use with***QD8 Attachments.***Use by 2016-03***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT E173049563***. Cutting and Shaping bone including bones of the spine and cranium.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBC·May 9, 2011
Sterile Bone Cutting Burrs model SIL-7-9 labeled in part:***SIL-7-9***QTY: 1***9 mm Fluted Ball.***Use with B-Silber***Attachment.***Use by 2015-01***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT D053031534***. Cutting and Shaping bone including bones of the spine and cranium.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBC·May 9, 2011