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Shenzhen AOJ Medical Technology Co., Ltd. FDA Approvals

0 new drug approvals and 13 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro510(k)Apr 1, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Apr 1, 2026
Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)510(k)Jun 23, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jun 23, 2025
Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo510(k)May 2, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 2, 2025
Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);510(k)Apr 30, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 30, 2025
Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)510(k)Apr 24, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 24, 2025
Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)510(k)Jul 1, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 1, 2024
Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)510(k)Oct 14, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Oct 14, 2023
Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B510(k)Jul 26, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 26, 2023
Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y510(k)Dec 20, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Dec 20, 2022
Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G510(k)Dec 1, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 1, 2022
Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107510(k)Oct 7, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Oct 7, 2022
Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E510(k)May 25, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	May 25, 2022
Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E510(k)Feb 18, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 18, 2022

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