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
81553–81576 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 2000
HRH-63 HEAD ARRAY COIL
K002774 · MOS
Mri Devices Corp.
Radiology · 71d
Cleared Nov 16, 2000
SSW-STERILE SOLUTION WARMER
K002859 · LHC
Kmi Kolster Methods, Inc.
General Hospital · 64d
Cleared Nov 16, 2000
SYNTHES 1.5MM TI BROW LIFT SCREW
K002935 · DZL
Synthes (Usa)
Dental · 56d
Cleared Nov 16, 2000
HERACERAM
K002993 · EIH
J.F. Jelenko & Co., Inc.
Dental · 52d
Cleared Nov 16, 2000
CREATININE PLUS
K003261 · JFY
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Nov 16, 2000
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
K003399 · IYN
Sonosite,Inc.
Radiology · 15d
Cleared Nov 16, 2000
ALLEGRO TB, ALLEGRO N
K003434 · KPS
Adac Laboratories
Radiology · 10d
Cleared Nov 15, 2000
PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
K001685 · MSE
Baxter Healthcare Corp
Gastroenterology & Urology · 167d
Cleared Nov 15, 2000
35/CD CINECONVERTER
K001841 · LMA
Tagarno A/S
Radiology · 149d
Cleared Nov 15, 2000
INTER-OP DURASUL ACETABULAR INSERTS (4MM)
K002575 · LWJ
Sulzer Orthopedics, Inc.
Orthopedic · 89d
Cleared Nov 15, 2000
LITWIN CRUICATE ANCHOR
K002600 · MBI
Instrument Makar, Inc.
Orthopedic · 86d
Cleared Nov 15, 2000
SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010
K002843 · EMA
Sultan Chemists, Inc.
Dental · 64d
Cleared Nov 15, 2000
SOLOBOND PLUS
K003153 · KLE
Voco GmbH
Dental · 36d
Cleared Nov 14, 2000
VBMAX
K000654 · CAH
A-M Systems, Inc.
General Hospital · 260d
Cleared Nov 14, 2000
WELCH ALLYN SPOT CHECK DEVICE
K002530 · DXN
Welch Allyn, Inc.
Cardiovascular · 90d
Cleared Nov 14, 2000
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1
K003308 · FLL
Microlife Corp.
General Hospital · 22d
Cleared Nov 13, 2000
PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
K001177 · LYR
Enteric Products, Inc.
Microbiology · 216d
Cleared Nov 13, 2000
NEXTSTITCH CARDIOVASCULAR VALVE SUTURE
K001440 · GAT
Genzyme Surgical Product (Genzyme...
General & Plastic Surgery · 189d
Cleared Nov 13, 2000
SOF-TACT DIABETES MANAGEMENT SYSTEM
K001993 · LFR
Abbott Laboratories
Chemistry · 137d
Cleared Nov 13, 2000
MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714
K002023 · LYR
Medmira Laboratories, Inc.
Microbiology · 133d
Cleared Nov 13, 2000
AMT SPINAL SYSTEM
K002059 · KWP
Micron Precision Engineering, Inc.
Orthopedic · 130d
Cleared Nov 13, 2000
ROVERS SPATULA
K002520 · HHT
Rovers Medical Devices B.V.
Obstetrics & Gynecology · 90d
Cleared Nov 13, 2000
SPARTAN MTS
K002521 · ELC
Spartan Marketing Group
Dental · 90d
Cleared Nov 13, 2000
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K002552 · KRO
Howmedica Osteonics Corp.
Orthopedic · 88d