43 results · 22ms · Sources: EU EUDAMED, US FDA

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ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JIS·April 15, 2025

Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile

FDA Recall
Open, Classified ·Biosense Webster, Inc.·Product code DYB·February 21, 2023

Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile

FDA Recall
Open, Classified ·Biosense Webster, Inc.·Product code DYB·February 21, 2023

CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with a three-way stopcock is provided for air or blood aspiration, and fluid infusion. The handle is equipped with a rotating collar to deflect the tip clockwise = 180 and counterclockwise = 180. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to allow fluoroscopic visualization. The sheath has electrodes on the outer surface to allow the sheath to interface with compatible CARTO" 3 Systems.

FDA Recall
Open, Classified ·Biosense Webster, Inc.·Product code DYB·February 16, 2024

LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code HGI·September 29, 2021

Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code HGI·September 29, 2021

LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code HGI·September 29, 2021

Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code HHI·September 12, 2019

LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code HGI·September 29, 2021

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical biopsy

FDA Recall
Open, Classified ·Sklar Instruments·Product code HCY·December 3, 2024

Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code HGI·September 29, 2021

Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157

FDA Recall
Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code HGI·May 25, 2022

Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code HGI·September 29, 2021

D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.

FDA Recall
Open, Classified ·Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany·Product code HCI·October 6, 2023

D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.

FDA Recall
Open, Classified ·Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany·Product code HCI·October 6, 2023

LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220

FDA Recall
Open, Classified ·CooperSurgical, Inc.·Product code HGI·September 29, 2021

D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.

FDA Recall
Open, Classified ·Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany·Product code HCI·October 6, 2023

F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)

FDA Recall
Open, Classified ·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code MHX·September 8, 2023

GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200

FDA Recall
Open, Classified ·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025

GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000

FDA Recall
Open, Classified ·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025