FDA.reportPublic FDA data

Pulse oximeter

Definition
An electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.
GUDID devices
540
Last updated
2026-06-13 06:05:13

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06924054300623BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.BM202026-06-04
00855111003279iHealthiHealth Labs Inc.PO32023-08-14
06924054300586BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.BM2000A2026-04-22
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.Nonin Fingerclip extension (with Ferrite)2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.Nonin Xpod2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.Masimo uSpO22026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.Masimo uSpO2 Fingerclip extension (with Ferrite)2026-05-27
00024291257561Handy SolutionsNavajo Manufacturing Company257562025-09-30
00031262100023HOMEDICSFKA DISTRIBUTING CO., LLCPX-131CO 2020-07-03
00031262109415HOMEDICSFKA DISTRIBUTING CO., LLCPX-150CO2023-05-26
00050428168721CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDMD300CN330R2025-09-30
00050428168738CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDMD300C2052025-09-30
00050428281826CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDCVS Health C202016-10-14
00050428389904CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDMD300CG152016-10-14
00050428419007CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDCVS Health C202016-10-14
00081832302159Vive PresicionVIVE HEALTH LLCDMD1028WHT2017-11-15
00093764604287A&D MedicalA&D COMPANY, LIMITEDUP-200BLE2023-01-31
00096295131376LEADERCardinal Health 110, Inc.53167812017-07-07
00096295131383LEADERCardinal Health 110, Inc.53167992017-07-07
00194346135219EquateWAL-MART STORES, INC.MD300CN5102023-09-13
00304040166130Henry ScheinHENRY SCHEIN, INC.57032222022-10-31
00311917044507WalgreensWALGREEN CO.6219012023-12-18
00311917054520WalgreensWALGREEN CO.8905682024-11-29
00311917054537WalgreensWALGREEN CO.8906252024-11-29
00370797149207Dr. Talbot'sTALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC149202020-10-23
00370797149214Dr. Talbot'sTALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC149212020-10-23
00370797149221Dr. Talbot'sTALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC149222020-10-23
00616784708812Pulse OximeterDynarex Corporation70882016-09-24
00616784708928Pulse OximeterDynarex Corporation70892016-09-24
00616784709017Pulse OximeterDynarex Corporation70902016-09-24
00628055787457DagammaDAGAMMA INC.Finger Pulse Oximeter DP2502020-05-28
00628693098045ByFloProductsByFlo LLCBFP50D12022-05-16
00634782062088Diagnostix™AMERICAN DIAGNOSTIC CORP21002016-09-21
00634782063030Diagnostix™AMERICAN DIAGNOSTIC CORP2100-2BK2016-09-21
00634782063047Diagnostix™AMERICAN DIAGNOSTIC CORP2100-2OR2016-09-21
00634782065294Advantage™ AMERICAN DIAGNOSTIC CORP22002018-10-17
00634782072827Adimals®AMERICAN DIAGNOSTIC CORP21502016-09-21
00634782093907Diagnostix™AMERICAN DIAGNOSTIC CORP2100CN2017-11-30
00642632950249MicrolifeMICROLIFE USA, INC.OXY550 BT2022-11-21
00768627870313Exacta Finger Pulse OximeterNORTH COAST MEDICAL, INC.NC870312016-09-01
00786585793505SEJOYJOYTECH HEALTHCARE CO.,LTDXM-1112026-03-28
00810038630007Easy@Home Fingertip Pulse OximeterEASY HEALTHCARE CORPORATIONEHP0352020-02-03
00810038631080Easy@Home Fingertip Pulse OximeterEASY HEALTHCARE CORPORATIONEHP0292020-08-10
00810038631103Easy@Home Pulse OximeterEASY HEALTHCARE CORPORATIONEHP0502022-02-17
00810053630013SANTAMEDICALXIAMEN ACURIO INSTRUMENT CO.,LTDSM-ACLED1502020-06-01
00810094574505CuraplexBOUND TREE MEDICAL, LLCMD300CN3102022-12-08
00810110200135BeurerBEURER NORTH AMERICA, L.P.PO132023-04-17
00810113570136Vive Precision VIVE HEALTH LLCDMD1066BLK2023-01-02
00810113574929ViveVIVE HEALTH LLCDMD1086WHT2024-01-12
00810113576794Vive Precision VIVE HEALTH LLCDMD1066WHT2024-04-24
00810115892380Diska NuLifeDiska LLCDNL-YM4022023-10-05
00812277030945CuraplexBOUND TREE MEDICAL, LLC69100MS2018-12-15
00815991022630BodyMedBOXOUT, LLCBDMOXMTRBLK2019-11-05
00815991025181BodyMedBOXOUT, LLCBDMPULSEOX2024-10-11
00817746021226Pulse OximeterBETTER BASICS, INC.MP-OX3002017-09-15
00818323022094Vive PrecisionVIVE HEALTH LLCDMD1034WHT2018-02-01
00822383173412DriveDrive Devilbiss Healthcare187052016-09-23
00822383252513DriveDrive Devilbiss Healthcare18715-PROBE2016-09-16
00822383259758DriveDrive Devilbiss Healthcare187202016-09-16
00822383549446DriveDrive Devilbiss Healthcare18720-ADPROBE2016-09-16
00822383549453DriveDrive Devilbiss Healthcare18720-PDPROBE2016-09-16
00822383579061DriveDrive Devilbiss HealthcareMQ30002016-09-16
00822383579078DriveDrive Devilbiss HealthcareMQ32002016-09-16
00833166000023PalmSat Handheld Oximeter with 8000Q2 sensorNONIN MEDICAL, INC.2500, 8000Q22024-09-05
00833166000047PALMSAT HANDHELD OXIMETER with 8000J sensorNONIN MEDICAL, INC.2500, 8000J2024-09-05
00843997008013RAD-GMASIMO CORPORATION92102024-02-28
00843997009997MightySatMASIMO CORPORATION97092024-08-19
00843997013789RAD-GMASIMO CORPORATION98952024-02-28
00843997017961MightySat MedicalMASIMO CORPORATION53562024-07-03
00845717010139Veridian HealthcareVERIDIAN HEALTHCARE LLC11-50Q12025-09-09
00847713000572microdot®Cambridge Sensors USA LLC1000-1002023-05-01
00848530061166Sunset Fingertip Pulse Oximeter SUNSET HEALTHCARE SOLUTIONS, INC.RES51002018-09-19
00848530061173Fingertip Pulse Oximeter with 6-way DisplaySUNSET HEALTHCARE SOLUTIONS, INC.RES51012018-09-19
00848530097653OximetersSUNSET HEALTHCARE SOLUTIONS, INC.RES51022024-08-01
00849686072570NoninNONIN MEDICAL, INC.32302016-09-03
00849686072600NoninNONIN MEDICAL, INC.Capno SW2017-03-13
00849686072754NoninNONIN MEDICAL, INC.95902016-08-24
00849686072761NoninNONIN MEDICAL, INC.95902016-08-24
00849686072778NoninNONIN MEDICAL, INC.95902016-08-24
00849686072785NoninNONIN MEDICAL, INC.95902016-08-24