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
145489–145512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 1986
T4 MONITOR STIMULATOR COMPUTER
K853476 · BXN
Regional Master Corp.
Anesthesiology · 153d
Cleared Jan 14, 1986
NERVE FINDER
K853477 · BXN
Regional Master Corp.
Anesthesiology · 153d
Cleared Jan 14, 1986
THE BODYLOG 500 RET THERAPEUTIC ELECTROMYOGRAPHICS
K854208 · HCC
Bodylog, Inc.
Neurology · 89d
Cleared Jan 14, 1986
MODEL 2120 SPIROSCREEN
K854403 · BZG
Gould, Inc.
Anesthesiology · 75d
Cleared Jan 14, 1986
NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928
K854717 · CEK
Nobel Scientific Industries, Inc.
Chemistry · 53d
Cleared Jan 14, 1986
VISION SGOT (AST)
K854982 · CIT
Abbott Laboratories
Chemistry · 33d
Cleared Jan 14, 1986
AUTO SUTURE TITANIUM SURGICAL STAPLES
K855047 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 28d
Cleared Jan 14, 1986
GLUCOSE (UV HEXOKIASE) REAGENT SET
K855153 · CFR
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
INORGANIC PHOSPHORUS REAGENT SET
K855154 · CEO
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET
K855156 · JPZ
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
ALBUMIN REAGENT SET
K855158 · CIX
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
LACTIC DEHYDROGENASE REAGENT SET
K855159 · CFJ
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET
K855186 · JPZ
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
ENZYMATIC CHOLESTROL REAGENT SET
K855187 · CHH
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET
K855189 · CIQ
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
TOTAL PROTEIN REAGENT SET
K855191 · CEK
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
ALKALINE PHOSPHATASE REAGENT SET
K855192 · CIO
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
CREATININE REAGENT SET
K855193 · CGX
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
GLUCOSE OXIDASE REAGENT SET
K855194 · CGA
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
DIRECT & TOTAL BILIRUBIN SET
K855195 · CIG
Technostics Intl.
Chemistry · 19d
Cleared Jan 14, 1986
INDI KWIK (TM) CO/TWO KIT
K855198 · JTR
Micro-Bio-Logics
Microbiology · 18d
Cleared Jan 13, 1986
SONOLINE SL-2(ULTRASOUND SCANNER)
K853008 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 181d
Cleared Jan 13, 1986
MODEL 3000 OPTICATH COMPUTER
K853018 · DXG
Oximetrix, Inc.
Cardiovascular · 180d
Cleared Jan 13, 1986
POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107
K853446 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 150d