Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
146089–146112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 13, 1986
BOMED-EEA
K853705 · DRX
Bomed Medical Mfr., Ltd.
Cardiovascular · 131d
Cleared Jan 13, 1986
PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA
K853714 · DQY
American Pharmaseal Div. Ahsc
Cardiovascular · 130d
Cleared Jan 13, 1986
CUSTOM CORONARY MANIFOLD KITS
K853749 · DTL
Procedure Products, Inc.
Cardiovascular · 126d
Cleared Jan 13, 1986
THE SPORTSTER (ELECTRIFIED WHEELCHAIR)
K853918 · INI
Amigo Sales, Inc.
Physical Medicine · 112d
Cleared Jan 13, 1986
MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO
K854059 · JHI
Bioclinical Systems, Inc.
Chemistry · 102d
Cleared Jan 13, 1986
AMENDMENT LIFEPAK 8, NPN 052
K854117 · DRO
Physio-Control Corp.
Cardiovascular · 96d
Cleared Jan 13, 1986
CRUISER
K854164 · ITI
Invacare Corp.
Physical Medicine · 90d
Cleared Jan 13, 1986
DEFIGARD 2000
K854175 · LDD
Odam
Cardiovascular · 90d
Cleared Jan 13, 1986
MEDSURG SELDINGER NEEDLE
K854294 · DRC
Medsurg Industries, Inc.
Cardiovascular · 80d
Cleared Jan 13, 1986
MOD TARGET/TIPS # 4011,4012,4511,4512,6912,4016
K854582 · DTB
Medtronic Vascular
Cardiovascular · 59d