FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
157153–157176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 1983
AMER. 400 SERIES TEMP. PROBES-RECTALL
K830839 · FLL
American Pharmaseal Div. Ahsc
General Hospital · 21d
Cleared Apr 06, 1983
OPEN ENDED URETERAL CATHETER
K830840 · GBM
Van-Tec, Inc.
Gastroenterology & Urology · 21d
Cleared Apr 06, 1983
BINOCULAR LOUPE
K830878 · HJH
Almore Intl., Inc.
Ophthalmic · 19d
Cleared Apr 06, 1983
CONNECTOR 5 IN 1, T-CONNECTOR
K830901 · GAZ
Medical Specialists IN Packaging
General Hospital · 16d
Cleared Apr 06, 1983
LUNDIA 10-2-N PARALLEL FLOW DIALYZER
K830905 · KOC
Gambro, Inc.
Gastroenterology & Urology · 16d
Cleared Apr 05, 1983
HERPES-IHA KIT
K822095 · KLC
Hillcrest Biologicals
Microbiology · 263d
Cleared Apr 05, 1983
PHADEBAS HUMYLASE CONTROL(H)
K823421 · JJX
Pharmacia, Inc.
Chemistry · 138d
Cleared Apr 05, 1983
ELISA PLUS SYSTEM
K830212 · JJE
William-Palmer Industries, Inc.
Chemistry · 71d
Cleared Apr 05, 1983
NOVA 7 TOTAL CALCIUM/IONIZED CALCIUM
K830213 · JFP
Nova Biomedical Corp.
Chemistry · 71d
Cleared Apr 05, 1983
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA
K830239 · CHH
Emd Chemicals, Inc.
Chemistry · 70d
Cleared Apr 05, 1983
ULTRA CHEM BUN-UV #65080-65081
K830241 · CDQ
Emd Chemicals, Inc.
Chemistry · 70d
Cleared Apr 05, 1983
YEAST IDENT
K830286 · JXB
Analytical Products, Inc.
Microbiology · 68d
Cleared Apr 05, 1983
ACTIVAT-PARTIAL THROMBO-PLASTIN
K830320 · GGW
Helena Laboratories
Hematology · 64d
Cleared Apr 05, 1983
LIQUID THROMBOPLASTIN REAGENT
K830331 · GJS
Helena Laboratories
Hematology · 63d
Cleared Apr 05, 1983
PHAKO KIT
K830379 · HQC
Vxtra Corp.
Ophthalmic · 60d
Cleared Apr 05, 1983
IRRIGATION/ASPIRATION KIT
K830385 · HQC
Vxtra Corp.
Ophthalmic · 60d
Cleared Apr 05, 1983
RADIOIMMUNOASSAY TEST SYSTEM PRL
K830412 · CFT
Monobind
Chemistry · 56d
Cleared Apr 05, 1983
HANDPIECE SYSTEM I/A
K830413 · HQZ
Uxtra Corp.
Ophthalmic · 56d
Cleared Apr 05, 1983
IV STAND
K830474 · HQC
Teknar, Inc.
Ophthalmic · 49d
Cleared Apr 05, 1983
POLYSTYRENE MICROTITER PLATE IMMUNOSOR
K830495 · DGO
Diagnostic Reagent Tech.
Microbiology · 48d
Cleared Apr 05, 1983
PEM-T
K830497 · JWZ
Hedeco
Microbiology · 48d
Cleared Apr 05, 1983
LEECO TESTOSTERONE DIAGNOSTIC KIT
K830512 · CDZ
Leeco Diagnostics, Inc.
Chemistry · 47d
Cleared Apr 05, 1983
EMIT-ST PHOTOMETER & DILUTER VERIFICA
K830518 · DIF
Syva Co.
Toxicology · 47d
Cleared Apr 05, 1983
B-GCG SYSTEM BY RIA
K830526 · JHI
Pcl-Ria, Inc.
Chemistry · 47d