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
149905–149928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 1985
EBSS W/O CA & MG
K850237 · KIT
Hazleton Research Products, Inc.
Microbiology · 44d
Cleared Mar 07, 1985
MENTOR PERCUTANEOUS MALECOT NEPHROSTOMY SET
K850287 · LJE
Mentor Corp.
Gastroenterology & Urology · 42d
Cleared Mar 07, 1985
NASAL SEPTAL BUTTON
K850492 · LFB
Santa Barbara Medco, Inc.
Ear, Nose, Throat · 27d
Cleared Mar 07, 1985
CRITIKON I.V. ADMINISTRAION SET
K850507 · FPA
Critikon Company, LLC
General Hospital · 27d
Cleared Mar 07, 1985
SELECTIVE STREP AGAR
K850557 · JSJ
Hardy Media
Microbiology · 24d
Cleared Mar 07, 1985
CORN MEAL AGAR W/POLYSORBATE 80, CORN MEAL W/POLYS
K850558 · JSG
Hardy Media
Microbiology · 24d
Cleared Mar 07, 1985
TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID
K850654 · FJI
Erika, Inc.
Gastroenterology & Urology · 16d
Cleared Mar 07, 1985
TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2
K850655 · FJI
Erika, Inc.
Gastroenterology & Urology · 16d
Cleared Mar 06, 1985
CARDIO ANALYZER MODEL 380
K844104 · LOS
Birtcher Corp.
Cardiovascular · 134d
Cleared Mar 06, 1985
ELECATH CARDIAC OUTPUT COMPUTER
K844682 · DXG
Electro-Catheter Corp.
Cardiovascular · 96d
Cleared Mar 06, 1985
PEEL-AWAY INTRODUCER SET
K844693 · DYB
Quinton, Inc.
Cardiovascular · 93d
Cleared Mar 06, 1985
IMED 980 VOLUMETRIC INFUSION PUMP
K844915 · FRN
Imed Corp.
General Hospital · 78d
Cleared Mar 06, 1985
MEDTRONIC 5061 ENDOCARDIAL PACING LEAD
K844974 · DTD
Medtronic Vascular
Cardiovascular · 72d
Cleared Mar 06, 1985
THE MEHESZ STIMULATING SYSTEM
K844994 · GZJ
Campden Medical , Ltd.
Neurology · 70d
Cleared Mar 06, 1985
KATENA MICROMETER KNIFE W/XTAL BLADE OF CRYSTAL SA
K850049 · HNN
Xtal Corp.
Ophthalmic · 57d
Cleared Mar 06, 1985
VERSA-FILL 120 & FILL SET 42-50
K850051 · LHI
Intl. Medical Industries
General Hospital · 57d
Cleared Mar 06, 1985
KM PRODUCTS SUCTION TIPS
K850240 · JOL
Km Products
General Hospital · 43d
Cleared Mar 06, 1985
WATERS 740 DATA MODULE-PLOTTER INTEGRATOR
K850272 · LDM
Millipore Corp.
Toxicology · 42d
Cleared Mar 06, 1985
PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR
K850576 · DTD
Pacesetter Systems
Cardiovascular · 21d
Cleared Mar 06, 1985
PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY &
K850596 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 19d
Cleared Mar 06, 1985
INTRA-ARC DISPOSABLE ARTHROPLASTY BURRS
K850645
Concept, Inc.
General & Plastic Surgery · 15d
Cleared Mar 06, 1985
C.A.D. PACK I -ARTHROSCOPY DRAPE PACK
K850714
Concept, Inc.
General & Plastic Surgery · 12d
Cleared Mar 05, 1985
ACCU-O-MATIC
K841427 · GZJ
Myomed, Inc.
Neurology · 333d
Cleared Mar 05, 1985
LIQUI-HEME HEMOGLOBIN CALIBRATORS
K842668 · KRZ
Biodiagnostic Intl
Chemistry · 238d