226 results · 17ms · 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.

Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603

FDA Enforcement
Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54612

FDA Enforcement
Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54614

FDA Enforcement
Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668

FDA Enforcement
Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24667

FDA Enforcement
Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613

FDA Enforcement
Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372

FDA Enforcement
Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374

FDA Enforcement
Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373

FDA Enforcement
Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration.

FDA Enforcement
Class II ·Terminated·Cook Inc.·April 25, 2018

Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.

FDA Enforcement
Class II ·Terminated·Cook Inc.·April 25, 2018

EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520

FDA Enforcement
Class II ·Ongoing·Cook Medical Incorporated·May 22, 2024

EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

FDA Enforcement
Class II ·Ongoing·Cook Medical Incorporated·May 22, 2024

Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·September 21, 2022

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·September 21, 2022

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·September 21, 2022

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·September 21, 2022

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·September 21, 2022

Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·September 21, 2022

Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·September 21, 2022