32 results · 22ms · 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.

Cook Hilal Embolization Microcoil, 6 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations.

FDA Recall
Terminated ·Cook, Inc.·Product code HCG·May 8, 2008

Cook Hilal Embolization Microcoil, 3 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations.

FDA Recall
Terminated ·Cook, Inc.·Product code HCG·May 8, 2008

Peel-Away Introducer set, Catheter introducer, sterile; Catalog Number: C-PLI-7.0-38-CPC-072491. William Cook Europe A/S, Cook Inc., Bloomington, IN 47404.

FDA Recall
Terminated ·Cook, Inc.·Product code DYB·December 7, 2007

Peel-Away Introducer set without wire guide, 7.0 FR X 15.5 CM. Catheter introducer, Accepts devices up to 7.0 French., sterile; Catalog Number: PLVW-7.0-38. Cook Inc., Bloomington, IN 47404

FDA Recall
Terminated ·Cook, Inc.·Product code DYB·December 7, 2007

Peel-Away Introducer set without wire guide, 7.0 FR X 15.5 CM. Catheter introducer, Accepts devices up to 7.0 French., sterile; Catalog Number: PLVW-7.0-35. Cook Inc., Bloomington, IN 47404

FDA Recall
Terminated ·Cook, Inc.·Product code DYB·December 7, 2007

Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .038" DIA., 50 CM long, straight. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLV-7.0-38. Cook Inc., Bloomington, IN 47404

FDA Recall
Terminated ·Cook, Inc.·Product code DYB·December 7, 2007

Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLV-7.0-35. Cook Inc., Bloomington, IN 47404.

FDA Recall
Terminated ·Cook, Inc.·Product code DYB·December 7, 2007

Catalog Number: C-TPNS-6.5-90-REDO+. Catheter introducer, Note: This product is not distributed in the U.S. and is sent to foreign affiliates who then apply additional labeling prior to sale in their countries. Cook Inc., Bloomington, IN 47404

FDA Recall
Terminated ·Cook, Inc.·Product code DYB·December 7, 2007

Cook TPN Double Lumen Catheter set; Catheter introducer, includes 6.0 FRENCH, 65 CM Silicone Catheter, 7.0 FR. Peel-Away Introducer Set, Wire Guide: .035" DIA., 30 CM long, Needle: 19UT Gage., 7 cm long, sterile; Catalog Number: C-TPNS-6.0D-65. Cook Inc., Bloomington, IN 47404.

FDA Recall
Terminated ·Cook, Inc.·Product code DYB·December 7, 2007

Peel-Away Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer, 9 CM long, Wire: .035" DIA., 30 CM long, 3 MM J needle: 18 ga., 4.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLIP-7.0-35. Cook Inc., Bloomington, IN 47404

FDA Recall
Terminated ·Cook, Inc.·Product code DYB·December 7, 2007

Minipuncture Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 9 CM long, Wire: .025" DIA., 30 CM long, 3 MM J needle: 20XT GA., 4.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLIP-7.0-25-E-MNP. Cook Inc., Bloomington, IN 47404

FDA Recall
Terminated ·Cook, Inc.·Product code DYB·December 7, 2007

Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA. Intended as a root canal filling material that is used in conjunction with gutta percha or silver endodontic points.

FDA Recall
Terminated ·Sybron Dental Specialties·Product code KIF·February 23, 2009

Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needles: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French, sterile, Catalog Number: C-PLI-7.0-35-X-1. Cook Inc., Bloomington, IN 47404

FDA Recall
Terminated ·Cook, Inc.·Product code DYB·December 7, 2007

Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French,sterile, Catalog Number: C-PLI-7.0-35. Cook Inc., Bloomington, IN 47404

FDA Recall
Terminated ·Cook, Inc.·Product code DYB·December 7, 2007

Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .038" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLI-7.0-38. Cook Inc., Bloomington, IN 47404

FDA Recall
Terminated ·Cook, Inc.·Product code DYB·December 7, 2007

Cook TPN Single Lumen Catheter set; Catheter introducer, includes 6.5 FRENCH, 90 CM Silicone Catheter, 7.0 FR. Peel-Away Introducer Set, Wire Guide: .035" DIA., 30 CM long, Needle: 18 Gage., 7 cm long, sterile; Catalog Number: C-TPNS-6.5-90-REDO. Cook Inc., Bloomington, IN 47404.

FDA Recall
Terminated ·Cook, Inc.·Product code DYB·December 7, 2007

K3 Engine File G-Pack, Product: Endodontic Pulp Canal File, Part Number: 830-9925. For use in root canal preparation.

FDA Recall
Terminated ·Ormco Corporation·Product code EKS·August 1, 2008

Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root canal.

FDA Recall
Terminated ·Ormco/Sybronendo·Product code EKS·December 12, 2012

EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01

FDA Recall
Terminated ·Phadia US Inc·Product code LSW·December 14, 2020

Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002

FDA Recall
Terminated ·Sybronendo·Product code EKM·October 27, 2009