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
143017–143040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1986
PHOENIX SYSTEM SEVEN.
K862592 · EWO
Nicolet Biomedical Instruments
Ear, Nose, Throat · 70d
Cleared Sep 16, 1986
FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT
K862813 · CGJ
Serono Diagnostics, Inc.
Chemistry · 54d
Cleared Sep 16, 1986
VENTRESCREEN II POLLENS ENZYME IMMUNOASSAY
K862901 · DHB
Ventrex Laboratories, Inc.
Immunology · 47d
Cleared Sep 16, 1986
FEKAL CHECK PARASITOLOGY CONTROL SLIDE
K862914 · JTR
Trend Scientific, Inc.
Microbiology · 46d
Cleared Sep 16, 1986
EMDS(TM) CALCIUM TESTPACKS, #67687/95
K863003 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 39d
Cleared Sep 16, 1986
EMDS(TM) ALBUMIN TESTPACKS, #67652/95
K863004 · CJW
Em Diagnostic Systems, Inc.
Chemistry · 39d
Cleared Sep 16, 1986
ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT
K863099 · JJK
Abbott Laboratories
Microbiology · 34d
Cleared Sep 16, 1986
CHOLINESTERASE (PTC) REAGENT
K863202 · DIH
Sigma Diagnostics, Inc.
Chemistry · 28d
Cleared Sep 16, 1986
ALT/GPT PROCEDURE
K863253 · CKA
Data Medical Associates, Inc.
Chemistry · 22d
Cleared Sep 16, 1986
BONE MARROW TRAY
K863326 · GAA
Packaging Technologies, Inc.
General & Plastic Surgery · 20d
Cleared Sep 16, 1986
CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100
K863423 · JTC
Plastic Injectors, Inc.
Microbiology · 12d
Cleared Sep 16, 1986
AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241
K863426 · JMO
American Research Products Co.
Chemistry · 12d
Cleared Sep 16, 1986
CASSETTE EMBOSSEER
K863483 · IDZ
Surgipath Medical Industries, Inc.
Pathology · 7d
Cleared Sep 15, 1986
VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN
K861808 · DSY
Cobe Laboratories, Inc.
Cardiovascular · 129d
Cleared Sep 15, 1986
MODEL 8-B CO2 LASER FOR GENERAL & PLASTIC SURGERY
K862423 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 82d
Cleared Sep 15, 1986
SKINTACT AG ELECTRODES
K862618 · DRX
Leon H. Lang Co.
Cardiovascular · 68d
Cleared Sep 15, 1986
LS9000 SUCTION BIOPSY NEEDLE
K862749 · GDM
Engineering, Inc.
General & Plastic Surgery · 56d
Cleared Sep 15, 1986
COMPANION 2500 PORTABLE VOLUME VENTILATOR
K862810 · CBK
Puritan Bennett Corp.
Anesthesiology · 53d
Cleared Sep 15, 1986
AKERSCAN COLORIMETRIC ANALYZER
K862908 · JJQ
Akers Medical Technologies
Chemistry · 46d
Cleared Sep 15, 1986
THERAPEUTIC DRUG MONITORING CONTROL SET
K862963 · JJY
American Monitor Corp.
Chemistry · 40d
Cleared Sep 15, 1986
ULTRASCAN CLINICAL ANALYZER
K862999 · JJQ
Specialty Medical Industries, Inc.
Chemistry · 38d
Cleared Sep 15, 1986
SERO-STAT R II STAPHYLOCOCCUS TEST
K863025 · LHT
Scott Laboratories, Inc.
Microbiology · 35d
Cleared Sep 15, 1986
ABBOTT TESTPACK (TM) HCG SERUM
K863032 · JHI
Abbott Laboratories
Chemistry · 35d
Cleared Sep 15, 1986
MEADOW FESCUE ALLERGEN DISC
K863098 · DHB
Immuno Nuclear Corp.
Immunology · 33d