FDA.reportPublic FDA data

Andy Smith

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30121840773012184077Andy Smith1N2026-01-018825 53 AVE ELMHURST,NY Elmhurst NY US 11373
30142336003014233600Andy Smith1N2026-01-018825 53 AVE Elmhurst NY US 11373
30174393703017439370Andy Smith1N2026-01-018825 53 AVE Elmhurst NY US 11373
30183664703018366470Andy Smith1N2026-01-018825 53 AVE Elmhurst NY US 11373
30263099873026309987Andy Smith1N2026-01-018825 53 AVE ELMHURST,NY Elmhurst NY US 11373
30278413293027841329Andy Smith1N2026-01-018825 53 AVE Elmhurst NY US 11373
30305046443030504644Andy Smith1N2026-01-018825 53 AVE Elmhurst NY US 11373
30315949043031594904Andy Smith1N2026-01-018825 53 AVE ELMHURST Elmhurst NY US 11373
30337969503033796950Andy Smith1N2026-01-018825 53 AVE ELMHURST,NY Elmhurst NY US 11373
30338156213033815621Andy Smith1N2026-01-018825 53 AVE ELMHURST,NY. Elmhurst NY US 11373
30386326753038632675Andy Smith1N2026-01-018825 53 AVE ELMHURST Elmhurst NY US 11373

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3294311111250811K253333Assisted Reproduction Laser System (Model ILS-400M)MRX2026-06-17
3294311410916255K242684Harioculture TL-16 Time-lapse IncubatorMQG2025-05-22
3128471259837247K242314Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)LLZ2025-09-11
3237091383072753K241956Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)FGB2025-01-22
3237091497543857K231725Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)GCJ2023-10-16
3237091026029125K231107Bronchoscope SystemEOQ2024-02-15
1887321799607575K222991Air Compression Leg Massager (model: EMK-701)IRP2023-03-15
3128471835722977K221499Minimally Invasive Prostate Surgery Navigation SystemLLZ2022-11-22
2140111713414146K211747Reusable NIBP CuffDXQ2021-09-23
2140111705899138K192404Patient Monitoring Cable (SpO2 Extension Cable)DSA2020-06-22
2140111948439036K173368Reusable & Disposable SpO2 SensorsDQA2018-08-31
2140111082115215K172797ECG Cable/LeadwiresDSA2018-02-28
2140111389353682
1887321405763290
2140111507378614
2140111606267741
2140111740121635
2140111751045527
2140111775697086
2140111811260112
2140111839261363
2140111882827062
2140111899230108
2140112022001892
2140112067158332
3294311004707753
3237091053329558
2898481072288304
2898481186387928
2898481217911490
2898481302161065
2898481306091020
2898481330482634
2898481337913708
3323741338918016
3309181382433940
3294311406263297
2898481418346675
2898481441487799
2898481459930810
2898481469264073
2898481491827620
3237091517181757
3223851522953909
3309181525420566
2140111530910411
3405241540135787
3309181561809166
3237091567360770
3237091620357204
3223851719816521
3294311766495522
3309181793254068
3320661825764490
3223851848162080
2898481902286632
2140111927415014
3323742071097698

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ22025-09-11
DSA22020-06-22
MRX12026-06-17
MQG12025-05-22
FGB12025-01-22
EOQ12024-02-15
GCJ12023-10-16
IRP12023-03-15
DXQ12021-09-23
DQA12018-08-31