220 results · 24ms · 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.

Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.

FDA Recall
Terminated ·Hologic, Inc·Product code NUA·March 31, 2016

CF InPlex ASR Card; Catalog Number: 95-0501.

FDA Recall
Terminated ·Hologic, Inc·Product code NUA·March 31, 2016

Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

FDA Recall
Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code HET·June 25, 2008

Injection Needle, LUER-lock,0.8mm, REF: 26175PD

FDA Recall
Open, Classified ·Karl Storz Endoscopy·Product code HET·October 24, 2023

(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; (c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Storz Scope, Catalog #88-9808; and (d) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Wolf Scope, Catalog #88-9809.

FDA Recall
Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code HET·February 23, 2022

Gynecare Morcellex Tissue Morcellator; Manufactured by: Ethicon Women's Health & Urology; A Division of ETHICON INC, a Johnson & Johnson Company, Somerville, NJ 08876

FDA Recall
Terminated ·Ethicon, Inc. US·Product code HET·September 28, 2009

Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.

FDA Recall
Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code HET·June 25, 2008

Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.

FDA Recall
Terminated ·Market-Tiers Inc·Product code HET·July 16, 2014

Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code HET·November 6, 2023

OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code HET·November 20, 2023

OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code HET·November 20, 2023

FlexTray Procedure Delivery System Endopath Gynecololgy Tray, Product #FN065.

FDA Recall
Terminated ·Ethicon Endo-Surgery·Product code HET·November 25, 2003

FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD063.

FDA Recall
Terminated ·Ethicon Endo-Surgery·Product code HET·November 25, 2003

Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000

FDA Recall
Terminated ·Guidant Cardiac Surgery·Product code HET·November 19, 2003

Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201, 620-030-301

FDA Recall
Terminated ·Stryker Endoscopy·Product code HET·June 2, 2006

FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD065.

FDA Recall
Terminated ·Ethicon Endo-Surgery·Product code HET·November 25, 2003

Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

FDA Recall
Terminated ·Olympus Corporation of the Americas·Product code HET·November 17, 2015

Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

FDA Recall
Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code HET·June 25, 2008

Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.

FDA Recall
Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code HET·June 25, 2008

Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE

FDA Recall
Open, Classified ·Karl Storz Endoscopy·Product code HET·February 27, 2024