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
143929–143952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 1986
BICARBONATE PROCEDURE
K861673 · KHS
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
CHLORIDE PROCEDURE
K861674 · CHJ
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 704
K861696 · JGS
Boehringer Mannheim Corp.
Chemistry · 57d
Cleared Jul 01, 1986
MODIFIED MODELS 8320/8322/8329/8316/8317/8318
K861719 · DXY
Medtronic Vascular
Cardiovascular · 60d
Cleared Jul 01, 1986
ERIE-NEB
K861865 · BTI
Erie Medical
Anesthesiology · 47d
Cleared Jul 01, 1986
BYRON SUCTION TIPS
K861878
Byron Medical
General & Plastic Surgery · 47d
Cleared Jul 01, 1986
UNISKAN II
K861897 · JJQ
Flow Laboratories, Inc.
Chemistry · 46d
Cleared Jul 01, 1986
HCG IRMA, CAT. NO. CR-1501
K862007 · JHI
Pacific Biotech, Inc.
Chemistry · 35d
Cleared Jul 01, 1986
SOMAS LIQUID URINE CONTROL
K862179 · JJY
Somas Medical Industries, Inc.
Chemistry · 22d
Cleared Jul 01, 1986
LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II
K862186 · JPK
Bio-Rad
Hematology · 22d
Cleared Jul 01, 1986
UREA NITROGEN (GLDH) REAGENT SET (UV)
K862210 · CDQ
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Jul 01, 1986
ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET
K862256 · CJE
Sterling Diagnostics, Inc.
Chemistry · 18d
Cleared Jul 01, 1986
AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS
K862299 · CIG
Amresco, Inc.
Chemistry · 14d
Cleared Jul 01, 1986
FUJITSU MALLEABLE - TIP BRAIN SPATULA
K862331 · HAO
Downs Surgical , Ltd.
Neurology · 12d
Cleared Jul 01, 1986
CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM
K862375 · DSI
Grandcor Medical Systems
Cardiovascular · 7d
Cleared Jul 01, 1986
TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM
K862415 · IWZ
Parexel Intl. Corp.
Radiology · 6d
Cleared Jul 01, 1986
FTI 100 MEDICAL THERMAL IMAGER
K862416 · LMC
Parexel Intl. Corp.
Radiology · 6d
Cleared Jun 30, 1986
ARTIS ULTRASOUND IMAGING SYSTEM
K853565 · IYO
Philips Medical Systems (Cleveland),...
Radiology · 308d
Cleared Jun 30, 1986
CARDIOSCAN DOPPLER OPTION
K860579 · JOP
Interspec, Inc.
Cardiovascular · 132d
Cleared Jun 30, 1986
INTELLIJECT INFUSION PUMP
K861207 · FRN
Intelligent Medicine, Inc.
General Hospital · 91d
Cleared Jun 30, 1986
INTELLIJECT MEDICATION SYRINGE
K861208 · FRN
Intelligent Medicine, Inc.
General Hospital · 91d
Cleared Jun 30, 1986
STORZ COMPUSCAN 68K
K861335 · IYO
Storz Instrument Co.
Radiology · 82d
Cleared Jun 30, 1986
META - HEALTH MODEL MTG III
K861771 · FLL
Meta Health, Inc.
General Hospital · 54d
Cleared Jun 30, 1986
HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER
K862020 · BYD
Intertech/Ohio
Anesthesiology · 33d