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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
164497–164520 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 1981
TRANSMITTER & RECEIVERS, TELEPHONE, ELEC
K810608 · DXH
Heart Check Systems, Inc.
Cardiovascular · 56d
Cleared May 01, 1981
VARIODRAIN
K810636 · GCY
Colmed, Ltd.
General & Plastic Surgery · 52d
Cleared May 01, 1981
THINLITH III UNIPOLAR CARDIAC PULSE GEN.
K810752 · DXY
Intermedics, Inc.
Cardiovascular · 42d
Cleared May 01, 1981
MODEL 230-05 CYBERLITH I BIPOL. PULSE G.
K810800 · DXY
Intermedics, Inc.
Cardiovascular · 39d
Cleared May 01, 1981
PRITCHARD SURFACE REPLACEMENT ELBOW
K810847 · JDB
Depuy, Inc.
Orthopedic · 35d
Cleared May 01, 1981
EEG TELEPHONE RECEIVER MODEL #AFR-J
K810872 · DXH
Telediagnostic Systems, Inc.
Cardiovascular · 31d
Cleared May 01, 1981
FECAL STAINING KIT
K810875 · KKJ
Jayco Pharmaceuticals
Pathology · 31d
Cleared May 01, 1981
NDM DIATEMP INFANT ELECTROSURG. DISP. P.
K810920 · HAM
Ndm Corp.
General & Plastic Surgery · 25d
Cleared May 01, 1981
ANTITHYROID ANTIBODY IMMUNOFLUORESCENT
K810982 · JZO
Immuno-Products Industries
Immunology · 18d
Cleared May 01, 1981
ANTISMOOTH MUSCLE ANTIBODY TEST SYS
K810983 · DBE
Immuno-Products Industries
Immunology · 18d
Cleared May 01, 1981
ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST
K810984 · DBM
Immuno-Products Industries
Immunology · 18d
Cleared May 01, 1981
ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT
K810985 · DHN
Immuno-Products Industries
Immunology · 18d
Cleared May 01, 1981
IBM 5885 DIGITAL ECG ACQUISITION CART
K810988 · DPS
Intl. Business Machines
Cardiovascular · 18d
Cleared May 01, 1981
IBM 5880 ACQUISITION & ANALYSIS CART TEL
K810989 · LOS
Intl. Business Machines
Cardiovascular · 18d
Cleared May 01, 1981
MICROERMA SYSTEM
K811001 · JQW
Dynatech Corp.
Toxicology · 18d
Cleared May 01, 1981
CC-100
K811016 · DPS
Anthro-Metrics Corp.
Cardiovascular · 16d
Cleared May 01, 1981
EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY
K811034 · LAR
Syva Co.
Toxicology · 15d
Cleared May 01, 1981
TRYPTIC SOY AGAR W/LECITHIN & TWEEN 80
K811052 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 15d
Cleared May 01, 1981
POLYETHYLENE MEDULLARY PLUG
K811060
Arthur A. Checchi, Inc.
General & Plastic Surgery · 14d
Cleared May 01, 1981
MODEL 230-06 CYBERLITH TM I BIPOLAR IN
K811066 · DXY
Intermedics, Inc.
Cardiovascular · 14d
Cleared May 01, 1981
VENES II
K811085 · DWL
Jung Products, Inc.
General Hospital · 10d
Cleared May 01, 1981
SUTURE REMOVAL SET(DISPLSABLE)
K811086 · KDD
Cunningham Woodland, Inc.
General & Plastic Surgery · 10d
Cleared May 01, 1981
MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL
K811087 · FSM
Cunningham Woodland, Inc.
General & Plastic Surgery · 10d
Cleared May 01, 1981
GELMAN ELECTROPHORESIS CONTROL
K811100 · JJY
Gelman Sciences, Inc.
Chemistry · 9d