Truer Medical Inc

FDA Filings

This page includes the latest FDA filings for Truer 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: 2032273
• FEI Number: 3003240904
• Name: TRUER MEDICAL, INC.
• Owner & Operator: TRUER MEDICAL, INC.
• Contact Address: 1050 NORTH BATAVIA, UNIT C --; Orange CA 92867 US
• Official Correspondent:
  • Tim - Truitt
  • x-714-6289785-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1050 N Batavia St Ste C ; ORANGE, CA 92867 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID 10859290006486 TRUER MEDICAL, INC.	Sharn by Marketlab	2024-11-06
GUDID 00859290006472 TRUER MEDICAL, INC.	HP to 3.5mm Phonojack Cable with Shrinkwrap 70309	2024-01-24
GUDID 10859290006462 TRUER MEDICAL, INC.	Truer Bougie Coiled	2023-10-02
GUDID 00859290006458 TRUER MEDICAL, INC.	400 Series Right Angle Cable (160 cm)	2023-07-27
GUDID 00859290006441 TRUER MEDICAL, INC.	400 Series Right Angle Cable (80 cm)	2023-07-27
GUDID 10859290006417 TRUER MEDICAL, INC.	Nasal Cannula 90413	2022-09-16
GUDID 00859290006236 TRUER MEDICAL, INC.	Truer Bougie	2022-09-06
GUDID 00859290006373 TRUER MEDICAL, INC.	400 Series Type Monitor Cable, Right Angle 70321	2022-07-14
GUDID 00859290006366 TRUER MEDICAL, INC.	HP 400 series type monitor cable 70320	2022-07-14
GUDID 20859290006278 TRUER MEDICAL, INC.	Gas Sampling Line 120'x.048'x.108' M/F 90101	2022-07-08
GUDID 10859290006356 TRUER MEDICAL, INC.	Pediatric Stylet 90201	2022-07-08
GUDID 10859290006325 TRUER MEDICAL, INC.	GAS SAMPLING LINE 120' X .050' X .112' M/M 90158	2022-07-08
GUDID 10859290006318 TRUER MEDICAL, INC.	GAS SAMPLING LINE 96'x.050'x.112' MM 90156	2022-07-08
GUDID 10859290006301 TRUER MEDICAL, INC.	GAS SAMPLING LINE 120'x.050'x.108' M/F 90151	2022-07-08
GUDID 10859290006295 TRUER MEDICAL, INC.	Gas Sampling Line 120'X.050'x.108' M/M 90150	2022-07-08
GUDID 10859290006288 TRUER MEDICAL, INC.	Gas Sampling Line 120'x.040'x.112' M/M 90148	2022-07-08
GUDID 00859290006397 TRUER MEDICAL, INC.	Pediatric Headstrap 90518	2022-07-08
GUDID 00859290006380 TRUER MEDICAL, INC.	Adult Headstrap 90517	2022-07-08
GUDID 00859290006342 TRUER MEDICAL, INC.	Adult Stylet 90200	2022-07-08
GUDID 00859290006335 TRUER MEDICAL, INC.	GAS SAMPLING LINE 120'X.060'X.112' M/M 90169	2022-07-08
GUDID 00859290006267 TRUER MEDICAL, INC.	Gas Sampling Line 120 x .048 x .108 M/M CO-EX 90100	2022-07-08
GUDID 00859290006076 TRUER MEDICAL, INC.	Truer Medical, Inc. ES 9000	2018-12-05
GUDID 00859290006205 TRUER MEDICAL, INC.	QuickSplint Kit Pouch 90600FG	2018-09-24
GUDID 00859290006151 TRUER MEDICAL, INC.	Orofacial Therapeutics 90000FG	2018-09-24
GUDID 40859290006135 TRUER MEDICAL, INC.	Truer Medical, Inc. SSP 400	2018-07-06
GUDID 30859290006145 TRUER MEDICAL, INC.	Truer Medical, Inc. TP 400	2018-07-06
GUDID 00859290006120 TRUER MEDICAL, INC.	Truer Medical, Inc. GP 14400	2018-07-06
GUDID 00859290006113 TRUER MEDICAL, INC.	Truer Medical, Inc. GP 9400	2018-07-06
GUDID 00859290006106 TRUER MEDICAL, INC.	Truer Medical, Inc. ES 2400	2018-07-06
GUDID 00859290006090 TRUER MEDICAL, INC.	Truer Medical, Inc. ES 1800	2018-07-06
GUDID 00859290006083 TRUER MEDICAL, INC.	Truer Medical, Inc. ES 1200	2018-07-06
GUDID 00859290006069 TRUER MEDICAL, INC.	Truer Medical, Inc. ES 24400H	2018-07-06
GUDID 00859290006052 TRUER MEDICAL, INC.	Truer Medical, Inc. ES 18400H	2018-07-06
GUDID 00859290006045 TRUER MEDICAL, INC.	Truer Medical, Inc. ES 12400H	2018-07-06
GUDID 00859290006038 TRUER MEDICAL, INC.	Truer Medical, Inc. ES 24400	2018-07-06
GUDID 00859290006021 TRUER MEDICAL, INC.	Truer Medical, Inc. ES 18400	2018-07-06
GUDID 00859290006014 TRUER MEDICAL, INC.	Truer Medical, Inc. ES 12400	2018-07-06
GUDID 00859290006007 TRUER MEDICAL, INC.	Truer Medical, Inc. ES 9400	2018-07-06
GUDID 20859290006223 TRUER MEDICAL, INC.	Adroit Surgical VB-3001	2018-06-26
GUDID 00859290006212 TRUER MEDICAL, INC.	Adroit surgical VB-2001	2018-06-26
CAT TRUER MEDICAL, INC.	Truer Medical Nasal Cannula	2015-09-11
BTK TRUER MEDICAL, INC.	Truer Medical, Inc. Head Strap	2015-09-11
PMN K111066 | MQC TRUER MEDICAL, INC.	TMJ QuickSplint	2013-05-28
PMN K111066 | MQC TRUER MEDICAL, INC.	Quick Spint	2013-05-28
PMN K111066 | MQC TRUER MEDICAL, INC.	Migratherapy LLC	2013-05-28
PMN K101244 | FLL TRUER MEDICAL, INC.	General Purpose Probes, Tympanic Probes, Skin Sensing Probes	2010-12-06
PMN K101244 TRUER MEDICAL INC.	SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE	2010-11-18
PMN K092716 | BZT TRUER MEDICAL, INC.	Esophageal Stethoscope	2010-06-08
KCD TRUER MEDICAL, INC.	Voir Bougie	2010-06-08
KCD TRUER MEDICAL, INC.	Tactical Bougie	2010-06-08
PMN K092716 TRUER MEDICAL INC.	ESOPHAGEAL STETHOSCOPE	2009-09-17
BSR TRUER MEDICAL, INC.	RPiS	2000-11-13
BSR TRUER MEDICAL, INC.	RAPID POSITIONING INTUBATION STYLET	2000-11-13
BSR TRUER MEDICAL, INC.	Intubation Stylet	2000-11-13
BYX TRUER MEDICAL, INC.	Gas Sampling Line	2000-10-26

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018112251221	Kaohsiung,China (Taiwan) -> Los Angeles, California	400 SERIES HP MONITOR CABLE 400 SERIES RIGHT ANGLE CABLE	5 CTN
2018092754023	Kaohsiung,China (Taiwan) -> Los Angeles, California	BLACK RUBBER HEAD HARNESS 40 CTNS RECEIVED IN .	40 CTN
2018042046732	Kaohsiung,China (Taiwan) -> Los Angeles, California	BLACK RUBBER HEAD HARNESS	37 CTN
2018042051088	Kaohsiung,China (Taiwan) -> Los Angeles, California	BLACK RUBBER HEAD HARNESS	37 CTN
2018010346743	Kaohsiung,China (Taiwan) -> Los Angeles, California	BLACK RUBBER HEAD HARNESS	35 CTN