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
147433–147456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 1985
BARRIER SURGICAL GOWN
K852870 · FYA
Surgikos, Inc.
General Hospital · 15d
Cleared Jul 23, 1985
IDS RAPID SS/U SYSTEM
K852871 · JSS
Innovative Diagnostic Systems, Inc.
Microbiology · 15d
Cleared Jul 23, 1985
MUG DISK
K852886 · JTO
Remel Co.
Microbiology · 14d
Cleared Jul 23, 1985
GENERAL DIAGNOSTICS RAPID E. COLI TEST
K852889 · JTO
Warner-Lambert Co.
Microbiology · 14d
Cleared Jul 23, 1985
NEISSERIA - KWIK PLUS
K852998 · JSX
Micro-Bio-Logics
Microbiology · 8d
Cleared Jul 22, 1985
MACULAR FUNCTION ANALYZER
K843227 · HOQ
Danek Medical, Inc.
Ophthalmic · 340d
Cleared Jul 22, 1985
ELECTRONYSTAGMOGRAPH (ENG RECORDER)
K850180 · GWN
Bio-Logic Systems Corp.
Neurology · 186d
Cleared Jul 22, 1985
V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES
K851082 · ENW
American V. Mueller
Ear, Nose, Throat · 126d
Cleared Jul 22, 1985
COMBINED MVS SYSTEMS
K851610 · HQE
Medical Instrument Development...
Ophthalmic · 98d
Cleared Jul 22, 1985
CEDIA TOTAL T4 ASSAY
K852164 · KLI
Microgenics Corp.
Chemistry · 63d
Cleared Jul 22, 1985
QUICK-CHEM CALIBRATION SET
K852260 · JIW
Seragen Diagnostics, Inc.
Chemistry · 59d
Cleared Jul 22, 1985
UROL-GUANT
K852295 · JJW
Dimension Diagnostics
Chemistry · 54d
Cleared Jul 22, 1985
TDX REA TRIGLYCERIDES
K852556 · JGW
Abbott Laboratories
Chemistry · 35d
Cleared Jul 22, 1985
ACA TOBRAMY-CIN ANALYTICAL TEST PACK
K852671 · KLB
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 28d
Cleared Jul 22, 1985
AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT
K852675 · JHI
Amersham Corp.
Chemistry · 28d
Cleared Jul 22, 1985
IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS
K852676 · CHL
Allied Instrumentation Laboratory
Chemistry · 28d
Cleared Jul 22, 1985
SGOT/ALT REAGENT
K852783 · CIT
Advanced Biomedical Methods, Inc.
Chemistry · 21d
Cleared Jul 22, 1985
ALKALINE PHOSPHATASE
K852784 · CJE
Advanced Biomedical Methods, Inc.
Chemistry · 21d
Cleared Jul 22, 1985
AMRESCO FLOW PAC TOTAL PROTEIN BIURET & BLANK CONC
K852844 · CEK
American Research Products Co.
Chemistry · 17d
Cleared Jul 19, 1985
MAMMOGRAPH III
K844119 · IZH
American Medical Imports, Inc.
Radiology · 269d
Cleared Jul 19, 1985
L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT
K850151 · BZO
Life Products, Inc.
Anesthesiology · 185d
Cleared Jul 19, 1985
JEE FRAME (VENTILATOR CIRCUIT SUPPORT)
K850924 · JAY
Vulcan Laboratories, Inc.
Anesthesiology · 136d
Cleared Jul 19, 1985
DIGITMATIC DM2
K851128 · JOM
Medimatic
Cardiovascular · 121d
Cleared Jul 19, 1985
HOMEDICA CEMENTED ACETABULAR COMPONENT 6262
K851565 · DXQ
Howmedica Corp.
Cardiovascular · 94d