Q Core Medical L T D

FDA Filings

This page includes the latest FDA filings for Q Core Medical L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010293992
FEI Number3010293992
NameQ CORE MEDICAL LTD
Owner & OperatorQ Core Medical Ltd
Contact Address29 Yad Haruzim St. Building 10
Netanya IL-NOTA 4250529 IL
Official Correspondent
  • Tally Eitan
  • 972-73-2388808-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address29 Yad Haruzim St.
Netanya HaMerkaz, 4250529 IL
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
Q-CORE MEDICAL LTD
 Multi-Pump Bracket Kit - US (4 units) 2022-11-14
Q-CORE MEDICAL LTD
 Communication Cable -US 2022-11-14
Q-CORE MEDICAL LTD
 Homecare Large Backpack 2022-11-14
Q-CORE MEDICAL LTD
 Infusion Pouch 500mL 2022-11-14
Q-CORE MEDICAL LTD
 Sapphire Multi-Pump Mounting Device 2022-11-14
Q-CORE MEDICAL LTD
 Multi-Pump Mounting System compatible with IPS- A 15171-000-00052022-05-24
Q-CORE MEDICAL LTD
 Sapphire Multi-Pump Mounting System Power Supply – US Multipack 15171-000-00022022-05-23
Q-CORE MEDICAL LTD
 AP223-01- MICROBORE WITH NON-VENTED SPIKE, BACK CHECK VALVE, FILTER AND NEE 12003-000-00332022-05-23
Q-CORE MEDICAL LTD
 Sapphire Power Supply 15072-000-00072022-05-23
Q-CORE MEDICAL LTD
 Sapphire M.T Infusion Pump Kit- US - S kit 17000-028-0072-S2022-05-23
Q-CORE MEDICAL LTD
 Sapphire Epidural Infusion Pump Kit – US 17000-031-00352022-05-23
Q-CORE MEDICAL LTD
 Panasonic Battery pack Label 05020-160-00012022-05-23
Q-CORE MEDICAL LTD
 Sapphire Multi-Pump Mounting System compatible with IPS 15171-000-00042022-05-23
Q-CORE MEDICAL LTD
 Multi-Pump Mounting System Compatible with IPS 15171-010-00052022-05-23
Q-CORE MEDICAL LTD
 Mini Cradle - US 15042-000-00102022-05-23
Q-CORE MEDICAL LTD
 Multi-Pump Mounting System Compatible with IPS- B Kit M 17000-020-00102022-05-23
Q-CORE MEDICAL LTD
 Multi-Pump Mounting System Compatible with IPS- B Kit 17000-020-00102022-05-23
Q-CORE MEDICAL LTD
 Mini Cradle 05040-300-00112022-05-23
Q-CORE MEDICAL LTD
 Mini Cradle with Splitter - US 17000-026-00072022-05-23
Q-CORE MEDICAL LTD
 Sapphire External Battery Pack 2022-05-23
Q-CORE MEDICAL LTD
 Bolus handle - US 15071-000-00052022-05-23
Q-CORE MEDICAL LTD
 Integrated power supply 15072-000-00102022-05-23
Q-CORE MEDICAL LTD
 PCA Lockbox 100 ml 15061-131-00042022-05-23
Q-CORE MEDICAL LTD
 PCA Lockbox 250mL 15063-000-00012022-05-23
Q-CORE MEDICAL LTD
 Sapphire Multi-Pump Mounting System Power Supply – US 17000-020-00082022-05-23
Q-CORE MEDICAL LTD
 Splitter - US 15043-000-00052022-05-23
Q-CORE MEDICAL LTD
 Sapphire power supply-US (interchangeble heads) 15072-000-00082022-05-23
Q-CORE MEDICAL LTD
 AP417-01- MICROBORE YELLOW MARKED INFUSION SET WITH NON-VENTED SPIKE AND NEURAXI 12004-000-00222022-05-23
Q-CORE MEDICAL LTD
 AP411-01- MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE, SLIDE CLAMP, NEED 12003-000-00782022-05-23
Q-CORE MEDICAL LTD
 AP213-01-MICROBORE INFUSION SET WITH NON-VENTED SPIKE, SLIDE CLAMP, ADMINISTRATI 12003-000-00112022-05-23
Q-CORE MEDICAL LTD
 AP504-01- UV RESISTANT INFUSION SET WITH VENTED / NON-VENTED DRIP CHAMBER, ROLLE 12000-000-00452022-05-23
Q-CORE MEDICAL LTD
 AP424-01- MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSET 12003-000-00242022-05-23
Q-CORE MEDICAL LTD
 AP410-01- SECONDARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, ROLLER CLA 12005-000-00072022-05-23
Q-CORE MEDICAL LTD
 AP402-01 MICROBORE EPIDURAL YELLOW MARKED WITH VENTD_NON-VENTED SPIKE 12004-000-00042022-05-23
Q-CORE MEDICAL LTD
 AP133-01- BLOOD SET WITH TWO NON-VENTED SPIKES, 2 ROLLER CLAMPS 12006-000-00102022-05-23
Q-CORE MEDICAL LTD
 AP240-01- MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSET 12003-000-00692022-05-23
Q-CORE MEDICAL LTD
 AP206-01- INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSETTE 12000-000-00222022-05-23
Q-CORE MEDICAL LTD
 AP204-01- MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSET 12003-000-00702022-05-23
Q-CORE MEDICAL LTD
 AP416-01- MICROBORE INFUSION SET WITH FEMALE LUER LOCK, FX ADMINISTRATIO 12003-000-00122022-05-23
Q-CORE MEDICAL LTD
 AP433-01- INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, FX ADMINISTRATION CA 12000-000-00442022-05-23
Q-CORE MEDICAL LTD
 AP423-01 MICROBORE WITH VENTED NON-VENTED SPIKE AND A BACK CHECK VALVE 12003-000-00232022-05-23
Q-CORE MEDICAL LTD
 AP409-01 PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VA 2022-05-23
Q-CORE MEDICAL LTD
 AP214-01- MICROBORE YELLOW MARKED INFUSION SET WITH VENTED/NON-VENTED SPIK 12004-000-00022022-05-23
Q-CORE MEDICAL LTD
 PCA Lockbox 500 ml 17000-062-00012022-05-23
Q-CORE MEDICAL LTD
 AP403-01 - MICROBORE WITH VENTED/NON-VENTED SPIKE 12003-000-00132022-05-23
Q-CORE MEDICAL LTD
 Sapphire M.T Infusion Pump Kit – US 17000-028-00722022-05-19
Q Core Medical Ltd.
Sapphire Infusion Pump, Sapphire Administration Sets2020-11-19
Q-CORE MEDICAL LTD
 AP214-01 - MICROBORE YELLOW MARKED WITH VENTED/NON VENTED SPIKE AND 0.2 FILTER 12004-000-00022019-06-25
Q-CORE MEDICAL LTD
 AP240-01 MICROBORE WITH NON-VENTED SPIKE,1.2 FILTER AND BACK CHECK VALVE 12003-000-00692019-06-25
Q-CORE MEDICAL LTD
 AP133-01 - BLOOD SET WITH 2 NON-VENTED SPIKES, 200 FILTER AND NEEDLESS Y-SITE 12006-000-00102019-06-25
Q-CORE MEDICAL LTD
 AP424-01 - MICROBORE WITH NON-VENTED SPIKE, FEMALE LUER LOCK WITH A BACK CHECK V 12003-000-00242019-06-25
Q-CORE MEDICAL LTD
 AP423- MICROBORE WITH NON-VENTED SPIKE AND A BACK CHECK VALVE 12003-000-00232019-06-25
Q-CORE MEDICAL LTD
 AP410-01 - SECONDARY INFUSION SET WITH VENTED/NONVENTED DRIP CHAMBER 12005-000-00072019-06-25
Q-CORE MEDICAL LTD
 AP433-01 INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND NEEDELESS Y-SITE 12000-000-00442019-06-25
Q-CORE MEDICAL LTD
 AP409-01 - PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK 12005-000-00032019-06-25
Q-CORE MEDICAL LTD
 AP504- UV RESISTANT INFUSION SET WITH VENTED/NONVENTED DRIP CHAMBER AND NEEDLELE 2019-06-20
Q-CORE MEDICAL LTD
 AAP402-01 - MICROBORE YELLOW MARKED WITH NON-VENTED SPIKE 2019-06-20
Q-CORE MEDICAL LTD
 AP206-01 INFUSION SET WITH NON-VENTED SPIKE, 1.2 FILTER AND NEEDELESS Y-SITE 12000-000-00222019-06-20
Q-CORE MEDICAL LTD
 AP204 MICROBORE WITH NON-VENTED SPIKE, 0.2 FILTER AND BACK CHECK VALVE 12003-000-00702019-06-20
Q-CORE MEDICAL LTD
 AP403-01 - MICROBORE WITH NON-VENTED SPIKE 12003-000-00132019-06-20
Q-CORE MEDICAL LTD
 Splitter- US 15043-000-00052019-03-26
Q-CORE MEDICAL LTD
 AP434-01 INFUSION SET WITH VENTED/NON-VENTED DRIP 12000-000-00302018-07-06
Q-CORE MEDICAL LTD
 AP433-01 INFUSION SET WITH VENTED/NON-VENTED DRIP 12000-000-00292018-07-06
Q-CORE MEDICAL LTD
 AP432-01 INFUSION SET WITH VENTED/NON-VENTED DRIP 12000-000-00282018-07-06
Q-CORE MEDICAL LTD
 AP431-01 INFUSION SET WITH VENTED/NON-VENTED DRIP 12000-000-00272018-07-06
Q-CORE MEDICAL LTD
 AP422-01 MICROBORE YELLOW MARKED WITH NON-VENTED S 12004-000-00132018-07-06
Q-CORE MEDICAL LTD
 AP416-01 MICROBORE WITH 2 FEMALE LUER LOCKS AND A 12003-000-00222018-07-06
Q-CORE MEDICAL LTD
 AP414-01 MICROBORE WITH NON-VENTED SPIKE, FEMALE L 12003-000-00212018-07-06
Q-CORE MEDICAL LTD
 AP403-01 MICROBORE WITH NON-VENTED SPIKE 12003-000-00202018-07-06
Q-CORE MEDICAL LTD
 AP402-01 MICROBORE YELLOW MARKED WITH NON-VENTED S 12004-000-00082018-07-06
Q-CORE MEDICAL LTD
 AP331-01 - NON PVC UV RESISTANT MICROBORE WITH VEN 12007-000-00052018-07-06
Q-CORE MEDICAL LTD
 AP233-01 - INFUSION SET WITH VENTED/NON-VENTED DRI 12000-000-00262018-07-06
Q-CORE MEDICAL LTD
 AP232-01 - MICROBORE INFUSION SET WITH VENTED/NON- 12003-000-00282018-07-06
Q-CORE MEDICAL LTD
 AP231-01 - INFUSION SET WITH VENTED/NON-VENTED DRI 12003-000-00272018-07-06
Q-CORE MEDICAL LTD
 AP224-01 MICROBORE YELLOW MARKED WITH VENTEDNON-VE 12004-000-00122018-07-06
Q-CORE MEDICAL LTD
 AP223-01 MICROBORE WITH NON-VENTED SPIKE, BACK CH 12003-000-00372018-07-06
Q-CORE MEDICAL LTD
 AP220-01 MICROBORE WITH NON-VENTED SPIKE, BACK CHE 12003-000-00362018-07-06
Q-CORE MEDICAL LTD
 AP214-01 MICROBORE YELLOW MARKED WITH VENTED/NON-V 12004-000-00072018-07-06
Q-CORE MEDICAL LTD
 AP213-01 MICROBORE WITH NON-VENTED SPIKE, 0.2μm FI 12003-000-00192018-07-06
Q-CORE MEDICAL LTD
 AP210-01 MICROBORE WITH NON-VENTED SPIKE AND 1.2μ 12003-000-00352018-07-06
Q-CORE MEDICAL LTD
 AP133-01 BLOOD SET WITH 2 NON-VENTED SPIKES, 200μ 12006-000-00032018-07-06
Q-CORE MEDICAL LTD
 Sapphire M.T. Infusion Kit- US 17000-028-00612018-07-06
Q-CORE MEDICAL LTD
 Mini Cradle - US 15042-000-00102018-07-06
Q-CORE MEDICAL LTD
 Integrated Power Supply US 15072-000-00102018-07-06
Q-CORE MEDICAL LTD
 SapphirePlus Infusion Kit - US 17000-033-00012018-07-06
Q-CORE MEDICAL LTD
 Sapphire Epidural Infusion Kit-US 17000-031-00272018-07-06
Q-CORE MEDICAL LTD
 Sapphire M.T. with Bolus and Splitter Kit -US 17000-028-00622018-07-06
Q-CORE MEDICAL LTD
 Multi-Pump Mounting System kit single pack for US 17000-020-00082018-07-06
Q-CORE MEDICAL LTD
 Sapphire External Battery Pack 15079-111-00012018-07-06
Q-CORE MEDICAL LTD
 PCA Lockbox 250mL 15063-000-00012018-07-06
Q-CORE MEDICAL LTD
 Sapphire Power Supply (fixed head) 15072-000-0007-ASM2018-07-06
Q-CORE MEDICAL LTD
 Bolus - US 15071-000-00052018-07-06
Q-CORE MEDICAL LTD
 PCA Lockbox 100 mL 15061-131-00042018-07-06
Q-CORE MEDICAL LTD
 Mini Cradle with Splitter- US 17000-026-00072018-07-06
Q CORE MEDICAL LTD
Sapphire2017-06-26
Q CORE MEDICAL LTD
Sapphire2017-06-26
Q Core Medical Ltd.
Sapphire Infusion Pump2017-03-27
Q CORE MEDICAL LTD
Sapphire Administration Set2014-12-16
Q CORE MEDICAL LTD
Sapphire Infusion Pump2014-12-16
Q CORE MEDICAL LTD
SAPPHIRE INFUSION PUMP2014-12-11
Q CORE MEDICAL LTD
SAPPHIRE ADMINISTRATION SET2014-08-05
Q CORE MEDICAL LTD
Sapphire Infusion Pump2013-11-14
Q CORE MEDICAL LTD
Administration Sets and Accessories2013-11-14
Q CORE MEDICAL LTD
SAPPHIRE INFUSION PUMP2013-10-17

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020031121162Piraievs,Greece -> New York/Newark Area, Newark, New JerseyMEDICAL PRODUCT HS CODE901890840019847 BOX
2020030527211Haifa,Israel -> New York/Newark Area, Newark, New JerseySLAC PUMPS AND ACCESSORIES HS 9018904 PCK
2020011041719Haifa,Israel -> New York/Newark Area, Newark, New JerseySLAC PUMPS HS 9018902 PCK
2019021913457Izmir ,Turkey -> New York, New YorkMEDICAL PRODUCT HS CODE 9018.90.84.00.1913 PKG
2019020442647Izmir ,Turkey -> New York/Newark Area, Newark, New JerseyMEDICAL PRODUCT HS CODE 9018.90.84.00.19762 BOX
201810257774Izmir ,Turkey -> New York/Newark Area, Newark, New JerseyMEDICAL PRODUCT HS CODE-90189084300 PKG
2018100254803Izmir ,Turkey -> New York/Newark Area, Newark, New JerseyMEDICAL PRODUCT HS CODE-90189084300 PKG
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