10,000 results
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38ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·February 18, 2020
TUBING SET
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·March 2, 2026
Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LHC·August 25, 2015
Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LHC·August 25, 2015
NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage: NORMOFLO H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer utilizes a solution reservoir housed in a controller unit (warmer). The recirculation solution is heated to present temperature in the reservoir, pumped though a heat exchanger ( a component of the Sets) and is returned to the reservoir for continuous recirculation. The NORMOFLO Warming products are typically used in clinical situations that may require rapid irrigation with warmed fluids.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code LHC·October 25, 2016
Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery.
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LHC·August 25, 2015
Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery.
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LHC·August 25, 2015
Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LHC·August 25, 2015
Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LHC·August 25, 2015
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Recall
Terminated
·Ecolab Inc·Product code LHC·August 18, 2015
Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery.
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LHC·August 25, 2015
Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery.
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LHC·August 25, 2015
Warmer, Irrigation Solution
FDA classification
FDA Class 1
·Warmer, Irrigation Solution
FHC, INC.
FDA registration
FHC, INC.·7 products·🇺🇸 United States
FHC, Inc
FDA registration
FHC, Inc·1 product·🇺🇸 United States
LAC-MAC LIMITED
FDA registration
LAC-MAC LIMITED·5 products·🇨🇦 Canada
HHC - PL
FDA UDI
HANDPIECE PARTS & REPAIRS, INC.·00810988031251·E-TYPE LOW SPEED SYSTEM 20k MOTOR W/1:1 STRAIGH...
HHC - PL
FDA UDI
HANDPIECE PARTS & REPAIRS, INC.·00810988031138·20,000 RPM MOTOR E-TYPE
FHC Adaptor
FDA UDI
MAZOR ROBOTICS LTD·07290109182728·
HHC - PL
FDA UDI
HANDPIECE PARTS & REPAIRS, INC.·00810988031145·E-TYPE STRAIGHT ATTACHMENT 1:1