24 results · 20ms · 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.

Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

FDA Recall
Terminated ·Teleflex Medical·Product code HCF·November 16, 2016

e-fix E20 power drive. The product is a wheelchair component/accessory.

FDA Recall
Terminated ·Frank Mobility Systems, Inc.·Product code ITI·August 1, 2004

e-fix E19 power drive. The product is a wheelchair component/accessory.

FDA Recall
Terminated ·Frank Mobility Systems, Inc.·Product code ITI·August 1, 2004

Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery

FDA Recall
Terminated ·Teleflex Medical·Product code HCF·March 24, 2016

Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma

FDA Recall
Terminated ·Abbott Laboratories Inc.·Product code CIX·March 10, 2010

First Responder Kit containing a 240-liter aluminum oxygen cylinder with individually packaged regulator, cannula, and bag mask resuscitator, all packaged in a shipping container labeled as: Product #L903, Desc FIRST RESPONDER KIT, Catalog #L903. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.

FDA Recall
Terminated ·Allied Healthcare Products Inc·Product code ECX·May 15, 2009

Roche Diagnostics ALBT2, Tina-quant Albumin Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04469658190. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of albumin concentration in serum and plasma.

FDA Recall
Terminated ·Roche Diagnostics Corp.·Product code CIX·June 11, 2008

Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-44P, CYL 02 ALUM 400 LITER, Catalog #31-10-0014. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.

FDA Recall
Terminated ·Allied Healthcare Products Inc·Product code ECX·May 15, 2009

Empty M9 aluminum oxygen cylinders packaged in shipping containers (1 per container) labeled as: Product #0022-57P, Desc: CYL 02 ALUM 240 LITER, Catalog #31-10-2012. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.

FDA Recall
Terminated ·Allied Healthcare Products Inc·Product code ECX·May 15, 2009

Empty Jumbo D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-96P, Desc CYL 02, JUMBO D, W/TYPE B POST, Catalog #31-10-2017. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.

FDA Recall
Terminated ·Allied Healthcare Products Inc·Product code ECX·May 15, 2009

Albumin Gen.2, Catalog 05166861190

FDA Recall
Terminated ·Roche Diagnostics Operations, Inc.·Product code CIX·August 27, 2020

Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.

FDA Recall
Terminated ·Western Scott Fetzer Company·Product code ECX·August 15, 2019

Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.

FDA Recall
Terminated ·Western Scott Fetzer Company·Product code ECX·August 15, 2019

SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA

FDA Recall
Terminated ·Sunstar Americas, Inc.·Product code EAX·March 23, 2021

Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.

FDA Recall
Terminated ·Western Scott Fetzer Company·Product code ECX·August 15, 2019

Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.

FDA Recall
Terminated ·Western Scott Fetzer Company·Product code ECX·August 15, 2019

Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-58 P, Desc CYL 02 ALUM 400 LITER, Catalog #31-10-2014. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.

FDA Recall
Terminated ·Allied Healthcare Products Inc·Product code ECX·May 15, 2009

Empty Jumbo D aluminum oxygen cylinders packaged in shipping containers labeled as: Product 0022-96, Desc CYL 02 ASSY., 637.2 LITER, Catalog #31-10-0017. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.

FDA Recall
Terminated ·Allied Healthcare Products Inc·Product code ECX·May 15, 2009

Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.

FDA Recall
Terminated ·Western Scott Fetzer Company·Product code ECX·August 15, 2019

Post Medical Valves VO870A-Y and VO870-A-Y-T PSI 2015, PSI 2015, CGA 870, Inlet .750 STDS, Gas services (Oxygen), PSI 2015, Aluminum Cylinders, InterMed Gas Products LLC Industrial Division, 2056 Vista Parkway West Palm Beach, FL 33411.

FDA Recall
Terminated ·Intermed Gas Products Corporation·Product code ECX·March 27, 2009