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

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175,820 results
151009–151032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 1984
ULTRA LYTE POTASSIUM REAGENT KIT
K843454 · CEM
Ultra Quest Diagnostics, Inc.
Chemistry · 83d
Cleared Nov 27, 1984
PETIT BANDS
K843587 · KGX
Micori Gifts, Inc.
General & Plastic Surgery · 102d
Cleared Nov 27, 1984
TRIGLYCERIDES REAGENT SYSTEM
K843832 · CDT
Fermco Biochemics, Inc.
Chemistry · 57d
Cleared Nov 27, 1984
UNIVERSAL-ERGOTEST
K843850 · ISD
Erich Jaeger, Inc.
Physical Medicine · 57d
Cleared Nov 27, 1984
LAUF-ERGOTEST
K843853 · IOL
Erich Jaeger, Inc.
Physical Medicine · 57d
Cleared Nov 27, 1984
ERGOTEST 40 & 45
K843855 · ISP
Erich Jaeger, Inc.
Physical Medicine · 57d
Cleared Nov 27, 1984
LAUF-ERGOTEST JUNIOR
K843859 · IOL
Erich Jaeger, Inc.
Physical Medicine · 57d
Cleared Nov 27, 1984
ULTIMA CHIROPRACTIC TABLES
K843877 · INQ
Elenex Medequip, Inc.
Physical Medicine · 56d
Cleared Nov 27, 1984
LOW PROFILE STEERABLE BALLOON DILATION
K843880 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 56d
Cleared Nov 27, 1984
POCKET OPHTHALMOSCOPE GH
K843897 · HLJ
Design Med. Corp.
Ophthalmic · 55d
Cleared Nov 27, 1984
COBAS FLUORESCENCE POLARIZATION MODULE
K843914 · JJG
Roche Diagnostic Systems, Inc.
Toxicology · 54d
Cleared Nov 27, 1984
STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3
K843986 · JJY
United Diagnostics, Inc.
Chemistry · 47d
Cleared Nov 27, 1984
GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3
K844018 · JJY
United Diagnostics, Inc.
Chemistry · 47d
Cleared Nov 27, 1984
SERACON TM SR IV
K844026 · JIX
Bhp Diagnostix, Inc.
Chemistry · 43d
Cleared Nov 27, 1984
SERACON TM SR III
K844027 · JIX
Bhp Diagnostix, Inc.
Chemistry · 43d
Cleared Nov 27, 1984
MOBILIMB HAND UNIT
K844033 · JFA
Danninger Medical Technology, Inc.
Physical Medicine · 43d
Cleared Nov 27, 1984
US 610
K844036 · IMI
Rich-Mar Corp.
Physical Medicine · 42d
Cleared Nov 27, 1984
LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER
K844044 · CEM
Medica Corp.
Chemistry · 41d
Cleared Nov 27, 1984
ENI BLOOD UREA NITROGEN REAGENT
K844065 · CDQ
Electro-Nucleonics Laboratories, Inc.
Chemistry · 40d
Cleared Nov 27, 1984
TDX SALICYLATE
K844070 · DKJ
Abbott Laboratories
Chemistry · 40d
Cleared Nov 27, 1984
WET DRESSING WATER-STERILE
K844095 · NAD
Absorbent Cotton Co., Inc.
General & Plastic Surgery · 35d
Cleared Nov 27, 1984
PHARMACIA STREP A DIRECT SWAB TEST
K844107 · GTZ
Pharmacia, Inc.
Microbiology · 35d
Cleared Nov 27, 1984
ADD-1
K844114 · JJE
Abbott Laboratories
Chemistry · 35d
Cleared Nov 27, 1984
ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT
K844167 · DKP
Bd Becton Dickinson Vacutainer...
Toxicology · 33d