10,000 results
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26ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Fischer Cone Biopsy Excisor - Medium Model: 900-151
FDA Recall
Terminated
·Apple Medical Corporation·Product code HGI·March 10, 2006
LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code HGI·June 18, 2019
Quantam 2000 Electrosurgical Generator, Part number 909075.
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code HGI·October 16, 2019
Fischer Cone Biopsy Excisor - Medium - Ext Model: 900-154
FDA Recall
Terminated
·Apple Medical Corporation·Product code HGI·March 10, 2006
Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.
FDA Recall
Terminated
·Gynex Corporation·Product code HGI·September 6, 2012
Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT430T, Casper Applier F/Std Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034
FDA Recall
Terminated
·Aesculap Inc·Product code HCI·November 1, 2007
Fischer Cone Biopsy Excisor Model: 900-157
FDA Recall
Terminated
·Apple Medical Corporation·Product code HGI·March 10, 2006
Fischer Cone Biopsy Excisor - Dual Sets Model: 900-156
FDA Recall
Terminated
·Apple Medical Corporation·Product code HGI·March 10, 2006
Quantam 2000 Electrosurgical Generator, Part number 909075-05W.
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code HGI·October 16, 2019
Fischer Cone Biopsy Excisor - Large Model: 900-152
FDA Recall
Terminated
·Apple Medical Corporation·Product code HGI·March 10, 2006
LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical current generated by a power supply to efficiently remove abnormal cells. The LEEP PRECISION INTEGRATED SYSTEM has been designed to provide an efficient workstation that can efficiently meet all the unique LEEP requirements of the clinic and practice-based facilities .
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code HGI·April 23, 2019
Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). The device is intended to be connected to a powered breast pump or adapted for use with a manual breast pump to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.
FDA Recall
Terminated
·Ameda, Inc.·Product code HGY·February 12, 2015
Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction.
FDA Recall
Terminated
·Ameda, Inc.·Product code HGY·February 12, 2015
PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The selector is attached to a flowmeter and is used to direct the outlet flow from any standard flowmeter to any one of the three outlets it provides.
FDA Recall
Terminated
·Precision Medical, Inc.·Product code BTM·March 5, 2010
ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code LPS·June 25, 2013
ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·July 9, 2014
Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
FDA Enforcement
Class II
·Terminated·BRAEMAR, INC.·July 10, 2013
Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
FDA Enforcement
Class II
·Terminated·BRAEMAR, INC.·July 10, 2013
N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LPS·January 11, 2017
Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
FDA Recall
Terminated
·Tecan US, Inc.·Product code JQW·July 23, 2018