Carilex Medical Inc

FDA Filings

This page includes the latest FDA filings for Carilex Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9710603
FEI Number3003513125
NameCarilex Medical, Inc.
Owner & OperatorCarilex Medical, Inc.
Contact AddressNo. 77, Keji 1st Rd.
Guishan Townshiip TW-TAO Taoyuan 333 TW
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressNo. 77, Keji 1st Rd.
Guishan District Taoyuan, 333 TW
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-06-28
CARILEX MEDICAL, INC.
2024-04-30
CARILEX MEDICAL, INC.
2024-04-30
CARILEX MEDICAL, INC.
2023-12-12
CARILEX MEDICAL, INC.
2023-12-12
CARILEX MEDICAL, INC.
2023-09-18
CARILEX MEDICAL, INC.
2023-09-06
CARILEX MEDICAL, INC.
2022-08-23
CARILEX MEDICAL, INC.
2022-08-01
CARILEX MEDICAL, INC.
2022-08-01
CARILEX MEDICAL, INC.
2022-08-01
CARILEX MEDICAL, INC.
2022-08-01
CARILEX MEDICAL, INC.
2022-08-01
CARILEX MEDICAL, INC.
2022-08-01
CARILEX MEDICAL, INC.
2022-08-01
CARILEX MEDICAL, INC.
2022-03-09
CARILEX MEDICAL, INC.
2022-03-09
CARILEX MEDICAL, INC.
2022-03-09
CARILEX MEDICAL, INC.
2022-03-09
CARILEX MEDICAL, INC.
2022-03-09
CARILEX MEDICAL, INC.
2022-03-09
CARILEX MEDICAL, INC.
2021-11-09
CARILEX MEDICAL, INC.
2021-11-09
CARILEX MEDICAL, INC.
2021-08-05
CARILEX MEDICAL, INC.
2021-07-27
CARILEX MEDICAL, INC.
2021-07-27
CARILEX MEDICAL, INC.
2021-07-06
CARILEX MEDICAL, INC.
2021-07-06
CARILEX MEDICAL, INC.
2021-05-13
CARILEX MEDICAL, INC.
2021-05-03
CARILEX MEDICAL, INC.
2021-03-24
CARILEX MEDICAL, INC.
2021-03-24
CARILEX MEDICAL, INC.
2021-03-24
CARILEX MEDICAL, INC.
2021-03-24
CARILEX MEDICAL, INC.
2021-03-24
CARILEX MEDICAL, INC.
2021-03-24
CARILEX MEDICAL, INC.
2021-03-24
CARILEX MEDICAL, INC.
2021-03-24
CARILEX MEDICAL, INC.
2021-03-24
CARILEX MEDICAL, INC.
2021-03-24
CARILEX MEDICAL, INC.
2021-03-24
CARILEX MEDICAL, INC.
2021-03-24
CARILEX MEDICAL, INC.
2021-03-24
CARILEX MEDICAL, INC.
2021-03-24
CARILEX MEDICAL, INC.
2020-12-28
CARILEX MEDICAL, INC.
2020-12-28
CARILEX MEDICAL, INC.
2020-12-28
CARILEX MEDICAL, INC.
2020-12-28
CARILEX MEDICAL, INC.
2020-12-28
CARILEX MEDICAL, INC.
2020-12-22
CARILEX MEDICAL, INC.
2020-12-22
CARILEX MEDICAL, INC.
2020-12-22
CARILEX MEDICAL, INC.
2020-04-01
CARILEX MEDICAL, INC.
2020-04-01
CARILEX MEDICAL, INC.
2020-04-01
CARILEX MEDICAL, INC.
2020-04-01
CARILEX MEDICAL, INC.
2020-04-01
CARILEX MEDICAL, INC.
2020-04-01
CARILEX MEDICAL, INC.
2020-04-01
CARILEX MEDICAL, INC.
2020-03-31
CARILEX MEDICAL, INC.
2020-03-31
CARILEX MEDICAL, INC.
2020-03-31
CARILEX MEDICAL, INC.
2020-03-31
CARILEX MEDICAL, INC.
2020-03-31
CARILEX MEDICAL, INC.
2020-03-31
CARILEX MEDICAL, INC.
2020-03-31
CARILEX MEDICAL, INC.
2020-03-30
CARILEX MEDICAL, INC.
2020-03-30
CARILEX MEDICAL, INC.
2020-03-30
CARILEX MEDICAL, INC.
2020-03-30
CARILEX MEDICAL, INC.
2020-03-30
CARILEX MEDICAL, INC.
2020-03-30
CARILEX MEDICAL, INC.
2020-01-29
CARILEX MEDICAL, INC.
2020-01-29
CARILEX MEDICAL, INC.
2020-01-29
CARILEX MEDICAL, INC.
2019-01-07
CARILEX MEDICAL, INC.
2019-01-07
CARILEX MEDICAL, INC.
2019-01-07
CARILEX MEDICAL, INC.
2018-12-31
Carilex Medical, Inc.
VT Canisters2018-12-11
Carilex Medical, Inc.
VT-2002018-09-05
Carilex Medical, Inc.
VT-1002018-09-05
Carilex Medical, Inc.
VT - 100, VT - 2002018-08-09
Carilex Medical, Inc.
VT Dressing Kits2018-06-10
Carilex Medical, Inc.
VT Dressing Kits2018-06-08
Carilex Medical, Inc.
H&R Relief Cushion2018-04-19
Carilex Medical, Inc.
H&R Relief Chair2018-04-19
Carilex Medical, Inc.
H&R Cari Chair2018-04-19
Carilex Medical, Inc.
H&R AirMax Cushion2018-04-19
Carilex Medical, Inc.
Cari Chair2018-04-19
Carilex Medical, Inc.
VT One; VT One 60 days2016-10-24
CARILEX MEDICAL, INC.
VT·One, VT·One 60days2016-10-13
Carilex Medical, Inc.
TheraFlo2014-09-12
Carilex Medical, Inc.
TheraFlo P.U. US 80 ~ 300 U85 H&R2014-09-12
Carilex Medical, Inc.
H&R TheraFlo2014-09-12
Carilex Medical, Inc.
H&R Relief Aire low air loss2014-09-12
Carilex Medical, Inc.
VT 1002012-12-09
Carilex Medical, Inc.
H&R AirMax2011-10-27
Carilex Medical, Inc.
ePhysio13-142001-10-11
Carilex Medical, Inc.
TheraFlo AP2001-10-11
Carilex Medical, Inc.
Revo P.U. Cari US2001-10-11
Carilex Medical, Inc.
Pillowed Air2001-10-11
Carilex Medical, Inc.
H&R Signa Relief2001-10-11
Carilex Medical, Inc.
H&R Revo2001-10-11
Carilex Medical, Inc.
H&R Relief Aire APM2001-10-11
Carilex Medical, Inc.
H&R Pedia Aire2001-10-11
Carilex Medical, Inc.
H&R Entrina2001-10-11
Carilex Medical, Inc.
H&R Dyno Relief2001-10-11
Carilex Medical, Inc.
H&R Dual2001-10-11
Carilex Medical, Inc.
H&R CozinyPlus2001-10-11
Carilex Medical, Inc.
Envelop Pump2001-10-11
Carilex Medical, Inc.
Entrix Lux M-Set2001-10-11
Carilex Medical, Inc.
EMS M-Set US2001-10-11
Carilex Medical, Inc.
Delta Force2001-10-11
Carilex Medical, Inc.
Delta Force Pro2001-10-11
Carilex Medical, Inc.
Centrius P.U. US2001-10-11
Carilex Medical, Inc.
Carilex Dual P.U.2001-10-11
Carilex Medical, Inc.
Bairrapy2001-10-11
Carilex Medical, Inc.
Airrapy Torso Wedge2001-10-11
Carilex Medical, Inc.
Airrapy Reusable Pillow2001-10-11
Carilex Medical, Inc.
Airrapy Blower2001-10-11
Carilex Medical, Inc.
Air Force 10002001-10-11
Carilex Medical, Inc.
360 Blanket2001-10-11

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091414195Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New JerseyMEDICAL USE MATTRESS & SPARE PART 28 CTNS = 3 PALLETS THE SAME THE SAME THE SAME THE SAME THE SAME28 CTN
2020072413030Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New JerseyMEDICAL USE PUMP655 CTN
2020071011401Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New JerseyMEDICAL USE PUMP & MATTRESS 210 CTNS (11 PLTS )560 CTN
2020071011401Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New JerseyMEDICAL USE PUMP & MATTRESS 350 CTNS (22 PLTS )560 CTN
202007045110Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New JerseyMEDICAL USE SPARE PARTS28 CTN
2020061911824Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New JerseyMEDICAL USE PUMP HS CODE: 8414.80440 CTN
202005305450Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New JerseyMEDICAL USE SPARE PART19 CTN
202005295478Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New JerseyMEDICAL USE SPARE PART19 CTN
202005235184Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey18 PALLETS(= 285 CTNS) MEDICAL USE PUMP & MAT .285 CTN

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