Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014054118

FEI Number

3014054118

Entity Name

FOGLESS INTERNATIONAL AB

City/State/Country

Vaggeryd Jonkoping, SE

Establishment Address

Storgatan 24, Vaggeryd Jonkoping SE567 32, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fogless International AB (Owner Number: 10055703)

Owner / Operator Contact Address

Storgatan 24, Vaggeryd, SE-F SE567 32, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SPIRO Speaking Valve SPIRO Tweezer SPIRO Humidifier

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2017-10-20
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-10-20
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2017-10-20

Official Correspondent

Jason Walton

US Agent Details

Frederick A. Stearns Business: Keller and Heckman LLP Email: stearns@khlaw.com Phone: (202) 4344288

Related Public Records

Same Entity

Fogless International AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142298	Covidien	Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff	2015-02-13
K182861	Covidien	Shiley Neonatal/Pediatric Tracheostomy Tube	2019-03-22
K142296	Covidien	Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula	2015-02-24
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2017	Teleflex Medical	2	Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.

Similar Registrations

Registration Number	Establishment Name	Location
2936999	Covidien	Lafayette, CO, US
3030733800	AD SUPPLY GROUP LIMITED	London London, City of, GB
1824231	ICU Medical, Inc.	Gary, IN, US
3030626857	PALM MEDICAL INTERNATIONAL BV	Buggenhout Oost-Vlaanderen, BE
3027579175	ICU Medical, Inc.	Highland, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014054118. Last updated year: 2026. Please use registration number 3014054118 when referencing this establishment in official correspondence.