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

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176,076 results
69649–69672 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 2004
QONTRAST
K040399 · LLZ
Amid
Radiology · 41d
Cleared Mar 29, 2004
LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON...
K040535 · JJY
Cliniqa Corporation
Chemistry · 27d
Cleared Mar 26, 2004
RETISCAN, RETIPORT
K023525 · GWE
Roland Consult
Neurology · 522d
Cleared Mar 26, 2004
ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550,...
K031421 · ELC
Nakanishi, Inc.
Dental · 326d
Cleared Mar 26, 2004
UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
K032386 · BTL
Impact Instrumentation, Inc.
Anesthesiology · 235d
Cleared Mar 26, 2004
FIXION HIP SYSTEM
K032730 · JDI
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 205d
Cleared Mar 26, 2004
QUANTUM LIGHT THERAPY SYSTEM
K032816 · NHN
Stargate International, Inc.
Physical Medicine · 199d
Cleared Mar 26, 2004
EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2,...
K033050 · DRF
Medtronic Vascular
Cardiovascular · 179d
Cleared Mar 26, 2004
ICON POLYAXIAL PEDICLE SCREW SYSTEM
K033090 · KWP
Alphatec Mfg., Inc.
Orthopedic · 179d
Cleared Mar 26, 2004
PRIZM KERATOME BLADE, MODEL MK8512M2
K033236 · HNO
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 172d
Cleared Mar 26, 2004
CHEETAH WHEELCHAIR
K033460 · IOR
R82 A/S
Physical Medicine · 148d
Cleared Mar 26, 2004
CLEARFIL PHOTO CORE PLT
K033970 · EBF
Kuraray Medical, Inc.
Dental · 95d
Cleared Mar 26, 2004
NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC
K034025 · DYB
Nmt Medical, Inc.
Cardiovascular · 88d
Cleared Mar 26, 2004
CONTOUR SE MICROSPHERES
K034068 · KRD
Boston Scientific Corp
Cardiovascular · 86d
Cleared Mar 26, 2004
VERTEBRON SCP CERVICAL PLATE SYSTEM
K040003 · KWQ
Vertebron, Inc.
Orthopedic · 84d
Cleared Mar 26, 2004
MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS
K040128 · HSD
Howmedica Osteonics Corp.
Orthopedic · 65d
Cleared Mar 26, 2004
ANTERIOR LUMBAR BUTTRESS SYSTEM
K040130 · KWQ
Seaspine
Orthopedic · 65d
Cleared Mar 26, 2004
CERASORB M ORTHO
K040216 · MQV
Curasan AG
Orthopedic · 56d
Cleared Mar 26, 2004
LOW PROFILE LUTHER SAFETY HUBER
K040527 · FPA
Luther Needlesafe Products, Inc.
General Hospital · 25d
Cleared Mar 26, 2004
ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D...
K040719 · IYO
Aloka Co., Ltd.
Radiology · 7d
Cleared Mar 25, 2004
INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
K031176 · BTT
Invacare Corp.
Anesthesiology · 346d
Cleared Mar 25, 2004
NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE
K033994 · LYC
Novabone Products, LLC
Dental · 92d
Cleared Mar 25, 2004
PRECISION VPS IMPRESSION MATERIAL
K040053 · ELW
Discus Dental, Inc.
Dental · 73d
Cleared Mar 25, 2004
HEMORRHAGE OCCLUDER PIN
K040109 · GDW
Tools For Surgery, LLC
General & Plastic Surgery · 65d