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
144889–144912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 1986
HOWMEDICA BIPOLAR PROSTHESIS
K861105 · KWY
Howmedica Corp.
Orthopedic · 21d
Cleared Apr 14, 1986
MASH DERMATOME
K861138 · GFD
Mecron Medical Products, Inc.
General & Plastic Surgery · 19d
Cleared Apr 11, 1986
PRESSURE REGULATOR
K853039 · CAN
Erie Medical
Anesthesiology · 266d
Cleared Apr 11, 1986
TRACHEAL TUBES
K853051 · BTO
Erie Medical
Anesthesiology · 266d
Cleared Apr 11, 1986
ECG-ELECTRODE(SWAROMED)
K853939 · DRX
D. Swarovski & Co.
Cardiovascular · 199d
Cleared Apr 11, 1986
ANESTHESIA VENTILATOR MODEL 100
K854202 · CAD
Rusz Instruments, Inc.
Anesthesiology · 178d
Cleared Apr 11, 1986
MODEL 509A PHYSIOCORDER AMBULATORY RECORDER
K854269 · DSH
Del Mar Avionics
Cardiovascular · 170d
Cleared Apr 11, 1986
FOX FASTIDIOUS TEST PANEL
K854525 · JWY
Beckman Instruments, Inc.
Microbiology · 149d
Cleared Apr 11, 1986
PROPHYLACTIC (CONDOM)
K854622 · HIS
Medelec Intl. Corp.
Obstetrics & Gynecology · 144d
Cleared Apr 11, 1986
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL
K855146 · LMS
Laserscope
Ear, Nose, Throat · 108d
Cleared Apr 11, 1986
MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL
K855227 · KLS
Bioclinical Systems, Inc.
Toxicology · 102d
Cleared Apr 11, 1986
TOTAL IGE-IRMA RIA KIT
K860032 · DGC
Diagnostic Products Corp.
Immunology · 95d
Cleared Apr 11, 1986
ANSWER PLUS AT HOME PREGNANCY TEST
K860090 · LCX
Armkel, LLC
Chemistry · 91d
Cleared Apr 11, 1986
ECHOCLONAL HTSH IRMA
K860288 · JLW
Bio-Rad
Immunology · 73d
Cleared Apr 11, 1986
MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)
K860367 · JGF
Alpkem Corp.
Chemistry · 67d
Cleared Apr 11, 1986
STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY
K860422 · KHQ
American Dade
Chemistry · 66d
Cleared Apr 11, 1986
EMIT D.A.U. CANNABINOID 20NG ASSAY
K860500 · LDJ
Syva Co.
Toxicology · 59d
Cleared Apr 11, 1986
ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD
K860525 · DLB
Roche Diagnostic Systems, Inc.
Toxicology · 59d
Cleared Apr 11, 1986
FLUOROSEAL, DENTIN SEALER AND CAVITY LINER
K860633 · LBH
Scientific Pharmaceuticals, Inc.
Dental · 50d
Cleared Apr 11, 1986
AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT
K860663 · JHY
Amresco, Inc.
Chemistry · 46d
Cleared Apr 11, 1986
DAHLBERG MODEL UT IN-THE-EAR HEARING AID
K860670 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 46d
Cleared Apr 11, 1986
ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL)
K860717 · CHH
Trace Scientific , Ltd.
Chemistry · 44d
Cleared Apr 11, 1986
CHARISMA HEARING AID
K860759 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 42d
Cleared Apr 11, 1986
SICKLE CELL REAGENT SET
K860812 · GHM
Michclone Associates, Inc.
Hematology · 38d