876 results · 38ms · 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.

CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.

FDA Recall
Terminated ·TERRIFIC CARE LLC 61 Willet St Bldg A-1, Fl 2 Passaic NJ 07055-1971·Product code GJS·December 20, 2018

Disposable Oxygen Mask & Bag, Adult Non-Rebreathing Mask w/Safety Vent and 84'' Tube; reorder no. 7022; SIngle Patient Only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008

FDA Recall
Terminated ·Medex Inc·Product code KGB·July 12, 2004

Medex 3000 Series Syringe Infusion Pumps

FDA Recall
Terminated ·Medex Inc·Product code CAJ·February 16, 2004

Disposable Water Trap with ''T'' for Ventilator Circuits; product reorder 6090; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008

FDA Recall
Terminated ·Medex Inc·Product code BYH·July 12, 2004

Ventilator Circuit with ''Y'' & elbow with 2 Water Traps, for use with/compatible with Bennett 7200; product reorder 6072WT; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008

FDA Recall
Terminated ·Medex Inc·Product code BZO·July 12, 2004

Disposable Water Trap with ''Y'' for Ventilator Circuits; product reorder 6091; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008

FDA Recall
Terminated ·Medex Inc·Product code BYH·July 12, 2004

Disposable Oxygen Mask & Bag, a High Concentration Non-Rebreathing Mask, complete w/Bag and One Way Valves, w/84'' Tube (3 in 1 mask); reorder no. 7020; SIngle Patient Only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008

FDA Recall
Terminated ·Medex Inc·Product code KGB·July 12, 2004

MX20170: Pediatric 40 In Sampling Kit w/10cc syringe, MX20443: LogiCal Single Pressure Kit, MX20470: Pressure Monitoring Kit, MX20477: LogiCal Double Kit, MX20730: Double LogiCal Kit, MX20760: Neonatal 18'' Add-On Kit, MX20822: TranStar Monitoring Set, MX4033: Kids Kit 18in (45.7cm) Add-on Blood Sampling Kit, MX4037: Kids Kit Add-On Blood Sampling Kit, MX700376: TranStar Triple Monitoring Kit, MX700377: Double TranStar Kit, MX7781R1: St Judes Secure Kit, MX8004CSTT: Novatrans Mtring Kit 60 (152.4cm) Single Line, MX8033T: Novatrans Kids Kit Neonatal Mtring, MX9502CSTT: TranStar 72in (183cm) Secure Double Kit, MX9504CSTT: TranStar 60in (152cm) Secure Monitoring Kit, MX9505CSTT: TranStar 84in (213) Secure Monitoring Kit, MX9506CSTT: TranStar 72in Secure Triple Kit, MX9533T: TranStar Kids Kit Neonatal Monitoring Kit, MX9534T: TranStar Kids Kit, MX9537T: TranStar Kids Kit, MX9602CSTA: LogiCal 72in (183cm) Secure Double Kit, MX9604CSTA: LogiCal 60in (152cm) Secure Monitoring Kit, MX9605CSTA: LogiCal 84in (213cm) Secure Monitoring Kit, MX9606CSTA: LogiCal 72in (183cm) Secure Monitoring Kit, MX9607CSTA: LogiCal Triple Secure Kit, MX9634A: LogiCal Kids Kit Neonatal Monitoring Kit, MX9637A: LogiCal Kids Kit Neonatal Monitoring Kit, SX02: Sterile Sample

FDA Recall
Terminated ·Medex Inc·Product code DQO·October 20, 2004

MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a tyvek pouch and is sold sterile. The product is labeled on the tyvek pouch with a stick-on label that reads in part ,''medex Dublin, OH 43016 USA***STERILE**MX6160R1 ** Custom CIPER**Lot #:**Latex Free***SINGLE USE''

FDA Recall
Terminated ·Medex Inc·Product code GWM·November 18, 2005

IPI Ventilator Circuit with 2 Water Traps, product reorder no. 6066; SIngle Patient Use Only; Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641

FDA Recall
Terminated ·Medex Inc·Product code BZO·July 12, 2004

MX441B, CVP Manometer. The product is packaged in a cardboard box. The units are packed ten (10) per case. The product is labeled on the outer case with a stick-on label that reads in part, ''**medex Dublin, OH 43016 USA**STERILE***MX441B CVP Manometer**Lot#***Latex Free''

FDA Recall
Terminated ·Medex Inc·Product code KRK·November 18, 2005

Medex 2000 Series Syringe Infusion Pumps. The 2001 series is a general use pump, 2001E is for German use, 2001G is for use in the UK, 2001T is for use in Taiwan, 2010iK is for use in Korea (the pumps with different languages have different syringes than those used in the U.S.), 001H has a different power cord connector, ''VX in the suffix means it is an evaluation pump, ''NFHU is not for human use; used in test labs for testing purposes, 2010 has an anesthesia mode built into the software, ''ZE are returned because of outdated software. They are refurbished or upgraded and re-distributed, 2010i, has an anesthesia mode and library mode for programming.

FDA Recall
Terminated ·Medex Inc·Product code CAJ·June 9, 2003

Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.

FDA Recall
Terminated ·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017

Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.

FDA Recall
Terminated ·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017

Portex 1000 ml Sterile Water USP Pour Bottle

FDA Recall
Terminated ·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017

Medline Prefilled 350 ml Sterile

FDA Recall
Terminated ·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017

Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.

FDA Recall
Terminated ·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017

Portex 550 ml Sterile Water Humidifier w/5psi Adapt.

FDA Recall
Terminated ·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017

Portex 350 ml Sterile Water Humidifier w/5psi Adapt.

FDA Recall
Terminated ·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017

Portex 550 ml Sterile Water Humidifier w/5psi Adapt.

FDA Recall
Terminated ·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017