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 Number: 9710603
• FEI Number: 3003513125
• Name: Carilex Medical, Inc.
• Owner & Operator: Carilex Medical, Inc.
• Contact Address: No. 77, Keji 1st Rd. ; Guishan Townshiip TW-TAO Taoyuan 333 TW
• US Agent:
  • ALAN P SCHWARTZ
  • mdi Consultants, Inc.
  • 516 4829001
  • 516 4820186
  • ALAN@MDICONSULTANTS.COM
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: No. 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	Device	Date
GUDID 14719873698445 CARILEX MEDICAL, INC.		2025-09-17
GUDID 04719873698431 CARILEX MEDICAL, INC.		2025-09-17
GUDID 04719873698424 CARILEX MEDICAL, INC.		2025-09-17
GUDID 14719873695987 CARILEX MEDICAL, INC.		2025-09-15
GUDID 14719873695741 CARILEX MEDICAL, INC.		2025-09-15
GUDID 14719873698407 CARILEX MEDICAL, INC.		2025-08-28
GUDID 14719873698391 CARILEX MEDICAL, INC.		2025-08-28
GUDID 14719873698384 CARILEX MEDICAL, INC.		2025-08-28
GUDID 14719873698216 CARILEX MEDICAL, INC.		2025-08-28
GUDID 04719873698417 CARILEX MEDICAL, INC.		2025-08-28
GUDID 04719873698370 CARILEX MEDICAL, INC.		2025-08-28
GUDID 04719873698363 CARILEX MEDICAL, INC.		2025-08-28
GUDID 04719873698356 CARILEX MEDICAL, INC.		2025-08-28
GUDID 04719873698349 CARILEX MEDICAL, INC.		2025-08-28
GUDID 04719873698332 CARILEX MEDICAL, INC.		2025-08-28
GUDID 04719873698240 CARILEX MEDICAL, INC.		2025-08-06
GUDID 04719873698233 CARILEX MEDICAL, INC.		2025-07-28
GUDID 04719873698226 CARILEX MEDICAL, INC.		2025-07-17
GUDID 04719873698189 CARILEX MEDICAL, INC.		2025-06-27
GUDID 04719873698172 CARILEX MEDICAL, INC.		2025-06-27
GUDID 14719873697110 CARILEX MEDICAL, INC.		2024-06-28
GUDID 14719873697103 CARILEX MEDICAL, INC.		2024-06-28
GUDID 14719873697097 CARILEX MEDICAL, INC.		2024-06-28
GUDID 14719873697080 CARILEX MEDICAL, INC.		2024-06-28
GUDID 14719873697073 CARILEX MEDICAL, INC.		2024-06-28
GUDID 14719873697066 CARILEX MEDICAL, INC.		2024-06-28
GUDID 14719873696939 CARILEX MEDICAL, INC.		2024-06-28
GUDID 14719873696915 CARILEX MEDICAL, INC.		2024-06-28
GUDID 04719873697052 CARILEX MEDICAL, INC.		2024-06-28
GUDID 04719873697045 CARILEX MEDICAL, INC.		2024-06-28
GUDID 04719873697038 CARILEX MEDICAL, INC.		2024-06-28
GUDID 04719873697021 CARILEX MEDICAL, INC.		2024-06-28
GUDID 04719873697014 CARILEX MEDICAL, INC.		2024-06-28
GUDID 04719873697007 CARILEX MEDICAL, INC.		2024-06-28
GUDID 04719873696994 CARILEX MEDICAL, INC.		2024-06-28
GUDID 04719873696987 CARILEX MEDICAL, INC.		2024-06-28
GUDID 04719873696970 CARILEX MEDICAL, INC.		2024-06-28
GUDID 04719873696963 CARILEX MEDICAL, INC.		2024-06-28
GUDID 04719873696956 CARILEX MEDICAL, INC.		2024-06-28
GUDID 04719873696949 CARILEX MEDICAL, INC.		2024-06-28
GUDID 04719873696925 CARILEX MEDICAL, INC.		2024-06-28
GUDID 04719873696901 CARILEX MEDICAL, INC.		2024-06-28
GUDID 04719873695898 CARILEX MEDICAL, INC.		2024-04-30
GUDID 04719873691296 CARILEX MEDICAL, INC.		2024-04-30
GUDID 04719873696864 CARILEX MEDICAL, INC.		2023-12-12
GUDID 04719873696857 CARILEX MEDICAL, INC.		2023-12-12
GUDID 14713616094785 CARILEX MEDICAL, INC.		2023-09-18
GUDID 04713616094764 CARILEX MEDICAL, INC.		2023-09-06
GUDID 04719873692972 CARILEX MEDICAL, INC.		2022-08-23
GUDID 04719873693382 CARILEX MEDICAL, INC.		2022-08-01
GUDID 04719873693368 CARILEX MEDICAL, INC.		2022-08-01
GUDID 04719873693283 CARILEX MEDICAL, INC.		2022-08-01
GUDID 04719873693122 CARILEX MEDICAL, INC.		2022-08-01
GUDID 04719873693108 CARILEX MEDICAL, INC.		2022-08-01
GUDID 04719873692989 CARILEX MEDICAL, INC.		2022-08-01
GUDID 00471987369297 CARILEX MEDICAL, INC.		2022-08-01
GUDID 04713616099295 CARILEX MEDICAL, INC.		2022-03-09
GUDID 04713616099264 CARILEX MEDICAL, INC.		2022-03-09
GUDID 04713616098687 CARILEX MEDICAL, INC.		2022-03-09
GUDID 04713616098670 CARILEX MEDICAL, INC.		2022-03-09
GUDID 04713616096379 CARILEX MEDICAL, INC.		2022-03-09
GUDID 04713616092104 CARILEX MEDICAL, INC.		2022-03-09
GUDID 04713616091916 CARILEX MEDICAL, INC.		2021-11-09
GUDID 04713616091879 CARILEX MEDICAL, INC.		2021-11-09
GUDID 04719873692576 CARILEX MEDICAL, INC.		2021-08-05
GUDID 04713616091749 CARILEX MEDICAL, INC.		2021-07-27
GUDID 04713616091718 CARILEX MEDICAL, INC.		2021-07-27
GUDID 04713616091558 CARILEX MEDICAL, INC.		2021-07-06
GUDID 04713616090742 CARILEX MEDICAL, INC.		2021-07-06
GUDID 04713616094467 CARILEX MEDICAL, INC.		2021-05-13
GUDID 04713616090322 CARILEX MEDICAL, INC.		2021-05-03
GUDID 04719873695676 CARILEX MEDICAL, INC.		2021-03-24
GUDID 04719873695607 CARILEX MEDICAL, INC.		2021-03-24
GUDID 04719873695430 CARILEX MEDICAL, INC.		2021-03-24
GUDID 04719873695409 CARILEX MEDICAL, INC.		2021-03-24
GUDID 04719873695065 CARILEX MEDICAL, INC.		2021-03-24
GUDID 04719873694464 CARILEX MEDICAL, INC.		2021-03-24
GUDID 04719873693740 CARILEX MEDICAL, INC.		2021-03-24
GUDID 04713616094634 CARILEX MEDICAL, INC.		2021-03-24
GUDID 04713616094603 CARILEX MEDICAL, INC.		2021-03-24
GUDID 04713616091343 CARILEX MEDICAL, INC.		2021-03-24
GUDID 04713616090285 CARILEX MEDICAL, INC.		2021-03-24
GUDID 04713616090216 CARILEX MEDICAL, INC.		2021-03-24
GUDID 04713616090186 CARILEX MEDICAL, INC.		2021-03-24
GUDID 04713616090179 CARILEX MEDICAL, INC.		2021-03-24
GUDID 04719873695577 CARILEX MEDICAL, INC.		2020-12-28
GUDID 04719873695546 CARILEX MEDICAL, INC.		2020-12-28
GUDID 04719873695034 CARILEX MEDICAL, INC.		2020-12-28
GUDID 04719873695003 CARILEX MEDICAL, INC.		2020-12-28
GUDID 04719873694945 CARILEX MEDICAL, INC.		2020-12-28
GUDID 04719873695881 CARILEX MEDICAL, INC.		2020-12-22
GUDID 04719873695515 CARILEX MEDICAL, INC.		2020-12-22
GUDID 04719873694976 CARILEX MEDICAL, INC.		2020-12-22
GUDID 04719873695287 CARILEX MEDICAL, INC.		2020-04-01
GUDID 04719873695263 CARILEX MEDICAL, INC.		2020-04-01
GUDID 04719873695256 CARILEX MEDICAL, INC.		2020-04-01
GUDID 04719873695232 CARILEX MEDICAL, INC.		2020-04-01
GUDID 04719873695218 CARILEX MEDICAL, INC.		2020-04-01
GUDID 04719873695188 CARILEX MEDICAL, INC.		2020-04-01
GUDID 04719873695157 CARILEX MEDICAL, INC.		2020-04-01
KDQ Carilex Medical, Inc.	VT Canisters	2018-12-11
PMN K173407 | OMP Carilex Medical, Inc.	VT-200	2018-09-05
PMN K173407 | OMP Carilex Medical, Inc.	VT-100	2018-09-05
PMN K173407 Carilex Medical, Inc.	VT - 100, VT - 200	2018-08-09
PMN K172725 | OMP Carilex Medical, Inc.	VT Dressing Kits	2018-06-10
PMN K172725 Carilex Medical, Inc.	VT Dressing Kits	2018-06-08
KIC Carilex Medical, Inc.	H&R Relief Cushion	2018-04-19
KIC Carilex Medical, Inc.	H&R Relief Chair	2018-04-19
KIC Carilex Medical, Inc.	H&R Cari Chair	2018-04-19
KIC Carilex Medical, Inc.	H&R AirMax Cushion	2018-04-19
KIC Carilex Medical, Inc.	Cari Chair	2018-04-19
PMN K161410 | OMP Carilex Medical, Inc.	VT One; VT One 60 days	2016-10-24
PMN K161410 CARILEX MEDICAL, INC.	VT·One, VT·One 60days	2016-10-13
IOQ Carilex Medical, Inc.	TheraFlo	2014-09-12
IOQ Carilex Medical, Inc.	TheraFlo P.U. US 80 ~ 300 U85 H&R	2014-09-12
IOQ Carilex Medical, Inc.	H&R TheraFlo	2014-09-12
IOQ Carilex Medical, Inc.	H&R Relief Aire low air loss	2014-09-12
PMN K112853 | OMP Carilex Medical, Inc.	VT 100	2012-12-09
IKY Carilex Medical, Inc.	H&R AirMax	2011-10-27
FNM Carilex Medical, Inc.	ePhysio13-14	2001-10-11
FNM Carilex Medical, Inc.	TheraFlo AP	2001-10-11
FNM Carilex Medical, Inc.	Revo P.U. Cari US	2001-10-11
FNM Carilex Medical, Inc.	Pillowed Air	2001-10-11
FNM Carilex Medical, Inc.	H&R Signa Relief	2001-10-11
FNM Carilex Medical, Inc.	H&R Revo	2001-10-11
FNM Carilex Medical, Inc.	H&R Relief Aire APM	2001-10-11
FNM Carilex Medical, Inc.	H&R Pedia Aire	2001-10-11
FNM Carilex Medical, Inc.	H&R Entrina	2001-10-11
FNM Carilex Medical, Inc.	H&R Dyno Relief	2001-10-11
FNM Carilex Medical, Inc.	H&R Dual	2001-10-11
FNM Carilex Medical, Inc.	H&R CozinyPlus	2001-10-11
FNM Carilex Medical, Inc.	Envelop Pump	2001-10-11
FNM Carilex Medical, Inc.	Entrix Lux M-Set	2001-10-11
FNM Carilex Medical, Inc.	EMS M-Set US	2001-10-11
FNM Carilex Medical, Inc.	Delta Force	2001-10-11
FNM Carilex Medical, Inc.	Delta Force Pro	2001-10-11
FNM Carilex Medical, Inc.	Centrius P.U. US	2001-10-11
FNM Carilex Medical, Inc.	Carilex Dual P.U.	2001-10-11
FNM Carilex Medical, Inc.	Bairrapy	2001-10-11
FNM Carilex Medical, Inc.	Airrapy Torso Wedge	2001-10-11
FNM Carilex Medical, Inc.	Airrapy Reusable Pillow	2001-10-11
FNM Carilex Medical, Inc.	Airrapy Blower	2001-10-11
FNM Carilex Medical, Inc.	Air Force 1000	2001-10-11
FNM Carilex Medical, Inc.	360 Blanket	2001-10-11

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091414195	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	MEDICAL USE MATTRESS & SPARE PART 28 CTNS = 3 PALLETS THE SAME THE SAME THE SAME THE SAME THE SAME	28 CTN
2020072413030	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	MEDICAL USE PUMP	655 CTN
2020071011401	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	MEDICAL USE PUMP & MATTRESS 210 CTNS (11 PLTS )	560 CTN
2020071011401	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	MEDICAL USE PUMP & MATTRESS 350 CTNS (22 PLTS )	560 CTN
202007045110	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	MEDICAL USE SPARE PARTS	28 CTN
2020061911824	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	MEDICAL USE PUMP HS CODE: 8414.80	440 CTN
202005305450	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	MEDICAL USE SPARE PART	19 CTN
202005295478	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	MEDICAL USE SPARE PART	19 CTN
202005235184	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	18 PALLETS(= 285 CTNS) MEDICAL USE PUMP & MAT .	285 CTN