Dental Device Guide
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Not currently registered with FDA under this name

Atrion Medical Products, Inc.

Arab, AL, United States. Named as applicant on 1 dental 510(k) clearance between 1997 and 1997. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
11997–1997
Markets registered in
1474 registrations outside the US
Establishments
0—
1997: 11990200020102020

510(k) clearances per year, 1990–2026

Registered in 14 markets

Where regulators' registries name Atrion Medical Products, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesCanada: 14 registrationsAustralia: 11 registrationsColombia: 8 registrationsBrazil: 7 registrationsSaudi Arabia: 7 registrationsSouth Korea: 7 registrationsTaiwan: 6 registrationsCosta Rica: 4 registrationsIsrael: 4 registrationsChina: 3 registrationsEgypt: 1 registrationsSerbia: 1 registrationsUnited Kingdom: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantAtrion Medical Products, Inc.1 clearances1997–1997Below
CanadaHealth CanadaRegistration holderATRION MEDICAL PRODUCTS, INC.142005–2026Pure Global AI
AustraliaTGAManufacturerAtrion Medical Products Inc112007–2026Pure Global AI
ColombiaINVIMAManufacturerATRION MEDICAL PRODUCTS, INCATRION MEDICAL PRODUCTS, INC. · ATRION MEDICAL PRODUCTS INC · +18—Pure Global AI
BrazilANVISAManufacturerATRION MEDICAL PRODUCTS INC.ATRION MEDICAL PRODUCTS INC · ATRION MEDICAL PRODUCTS, INC.72005–2025Pure Global AI
Saudi ArabiaSFDAManufacturerAtrion Medical Products, IncAtrion Medical Products · Atrion Medical Products, Inc.7—Pure Global AI
South KoreaMFDSManufacturerAtrion Medical Products, Inc.Atrion Medical Products Inc.72002–2020Pure Global AI
TaiwanTFDAManufacturerATRION MEDICAL PRODUCTS, INC.62006–2026Pure Global AI
Costa RicaMinisterio de SaludManufacturerAtrion Medical Products, Inc.ATRION MEDICAL PRODUCTS, INC.4—Pure Global AI
IsraelAMARManufacturerAtrion Medical Products, Inc.Atrion Medical Products Inc · Atrion Medical Products Inc.4—Pure Global AI
ChinaNMPARegistration holder阿特瑞恩医疗产品有限公司Atrion Medical Products, Inc.3—Pure Global AI
EgyptEDAManufacturerAtrion Medical Products, Inc ,12024–2024Pure Global AI
SerbiaALIMSManufacturerAtrion Medical Products, Inc.12024–2024Pure Global AI
United KingdomMHRAManufacturerAtrion Medical Products, Inc.1—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

510(k) clearances

Clearances on which FDA names Atrion Medical Products, Inc. as the applicant.

Decided510(k)DeviceDevice type
23 May 1997K971100ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOREIA Operative Dental Unit

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.