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
150937–150960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 1984
THYMATRON
K843923 · QGH
Somatics, Inc.
Neurology · 59d
Cleared Dec 03, 1984
ENZYGNOST BETA-2 MICROGLOBULIN TEST
K843967 · JZG
Behring Diagnostics, Inc.
Microbiology · 53d
Cleared Dec 03, 1984
C-22 PIT & FISSURE SEALANT
K844057 · EBC
Pentron Corp.
Dental · 46d
Cleared Dec 03, 1984
RIONET HEARING AID HB-34AS
K844059 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 46d
Cleared Dec 03, 1984
TA-201 CLINICAL AUDIOMETER
K844069 · EWO
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 46d
Cleared Dec 03, 1984
ORAPIK PERIODONTAL SCALER
K844238 · JET
Dental Concepts, LLC
Dental · 32d
Cleared Dec 03, 1984
STARKET MODEL HMS
K844275 · ETW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 28d
Cleared Dec 03, 1984
TIGER BAND
K844324 · DZN
World Wide Outdoor Marketing
Dental · 26d
Cleared Dec 03, 1984
OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE
K844326 · EBF
Coe Laboratories, Inc.
Dental · 26d
Cleared Dec 03, 1984
SURFLEX F
K844329 · ELW
G-C Intl. Corp.
Dental · 26d
Cleared Dec 03, 1984
SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS
K844349 · ELM
Ivoclar USA, Inc.
Dental · 24d
Cleared Nov 30, 1984
COUNT-A-PART PLUS
K841809 · JPK
Diagnostic Technology, Inc.
Hematology · 213d
Cleared Nov 30, 1984
TONGUE DEPRESSOR
K842461 · FMA
The Torrent Corp.
General Hospital · 161d
Cleared Nov 30, 1984
RESOLVE-CSF
K843122 · DFI
Isolab, Inc.
Chemistry · 114d
Cleared Nov 30, 1984
HEPARIN ACA ANALYTICAL TEST PACK
K843201 · KFF
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 108d
Cleared Nov 30, 1984
HEPARIN CALIBRATOR ACA
K843202 · KFF
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 108d
Cleared Nov 30, 1984
LKB 2230 ROTARY ONE
K843505 · IDO
Lkb Instruments, Inc.
Pathology · 85d
Cleared Nov 30, 1984
LKB 2189 ULTROPROCESSOR
K843506 · IEO
Lkb Instruments, Inc.
Pathology · 85d
Cleared Nov 30, 1984
K-APATITE 20-40 MESH K-APATITE 40-60
K843557 · ELE
Katecho, Inc.
Dental · 81d
Cleared Nov 30, 1984
CAPILLARY BLOOD COLLECTION TUBE
K843608 · GIO
Medical Technomics, Ltd.
Hematology · 78d
Cleared Nov 30, 1984
I.V. PUMP ADMINISTRATION SET
K843949 · FRN
Travenol Laboratories, S.A.
General Hospital · 52d
Cleared Nov 30, 1984
MICROTENS 7757 T.E.N.S. STIMULATOR
K844017 · GFJ
Rabar, Inc.
General & Plastic Surgery · 46d
Cleared Nov 30, 1984
NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN
K844079 · KLK
Novametrix Medical Systems, Inc.
Anesthesiology · 42d
Cleared Nov 30, 1984
GAINOR MEDICAL FLOWMAX NEEDLES
K844305 · FMI
Gainor Medical
General Hospital · 24d