178 results · 19ms · 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.

Datex-Ohmeda Cardiocap/5 Patient Monitors

FDA Recall
Terminated ·Datex-Ohmeda Inc One Ohmeda·Product code MHX·October 17, 2003

Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100

FDA Recall
Terminated ·Boston Scientific Corporation One Boston·Product code FGE·December 20, 2006

Wallstent Endoscopic Biliary Endoprosthesis 10mm x 60mm, UPN H965430500

FDA Recall
Terminated ·Boston Scientific Corporation One Boston·Product code FGE·December 20, 2006

HTA Console System, 110 Volt, Product Number: 56000 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)

FDA Recall
Terminated ·Boston Scientific Corporation One Boston·Product code MNB·January 24, 2007

EndoVive Safety PEG Kits 20 F Universal Product Number (UPN): MOO566460 The product provides nutrition directly into the stomach of adult and pediatric patients who are unable to consume by conventional methods.

FDA Recall
Terminated ·Boston Scientific Corporation One Boston·Product code KNT·June 17, 2008

Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units (The S/5 units are a later version of the AS/3 units. The conversion from AS3 to S5 occurred during the summer of 2000. This change was mainly a product name change, with a slight color variation to the shade of white being used externally on the machine. There were no design or feature and function modifications when the name change occurred.)

FDA Recall
Terminated ·Datex-Ohmeda Inc One Ohmeda·Product code BSZ·February 3, 2004

Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, Part Number 1406-8216-000, used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine, in a Magnetic Reasonance Suite.

FDA Recall
Terminated ·Datex-Ohmeda Inc One Ohmeda·Product code CBN·April 16, 2004

Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-866, UPN M001198660, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311

FDA Recall
Terminated ·Boston Scientific Corporation One Boston·Product code DQY·February 7, 2008

Wallstent Endoscopic Biliary Endoprosthesis 10mm x 80mm, UPN H965430600

FDA Recall
Terminated ·Boston Scientific Corporation One Boston·Product code FGE·December 20, 2006

Datex-Ohmeda S/5 Anesthesia Delivery Units

FDA Recall
Terminated ·Datex-Ohmeda Inc One Ohmeda·Product code BSZ·July 15, 2003

Boston Scientific NexStent Monorail 5F Carotid Stent and Monorail Delivery System, Manufactured by: Endotex International Systems, Inc. 10231 Bubb Road Cupertino, CA 95014 USA

FDA Recall
Terminated ·Boston Scientific Corporation One Boston·Product code NIM·May 1, 2007

Wallstent Endoscopic Biliary Endoprosthesis 10mm x 40mm, UPN H965430400

FDA Recall
Terminated ·Boston Scientific Corporation One Boston·Product code FGE·December 20, 2006

Wallstent Endoscopic Biliary Endoprosthesis 8mm x 80mm, UPN H965430300

FDA Recall
Terminated ·Boston Scientific Corporation One Boston·Product code FGE·December 20, 2006

HTA Console System, 230 Volt, Product Number: 56001 DO- English Demonstration Evaluation Unit (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)

FDA Recall
Terminated ·Boston Scientific Corporation One Boston·Product code MNB·January 24, 2007

28CM ALTA EXCHANGE KIT Model: AL23SH28 XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free.

FDA Recall
Terminated ·Spire Biomedical, Inc. One Patriots Park·Product code MSD·October 23, 2009

40CM DECATHLON GOLD STD KIT Models: DEC35SH40 and DEC35SH40-K DECATHLON GOLD 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.

FDA Recall
Terminated ·Spire Biomedical, Inc. One Patriots Park·Product code MSD·October 23, 2009

55CM DECATHLON STD KIT Models: DE50SH55 and DE50SH55-K 15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis.

FDA Recall
Terminated ·Spire Biomedical, Inc. One Patriots Park·Product code MSD·October 23, 2009

24CM ALTA LR GOLD STD KIT Model: ALC19SH24 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.

FDA Recall
Terminated ·Spire Biomedical, Inc. One Patriots Park·Product code MSD·October 23, 2009

36CM DECATHLON FUNNEL TIP STD KIT Model: DF31SH36 DECATHLON FUNNEL TIP 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free

FDA Recall
Terminated ·Spire Biomedical, Inc. One Patriots Park·Product code MSD·October 23, 2009

Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged

FDA Recall
Terminated ·Greiner Bio-One North America, Inc.·Product code GIM·August 20, 2021