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
45289–45312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 2012
CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL...
K112539 · IYO
Leiker Regulatory & Quality Consulting
Radiology · 151d
Cleared Jan 30, 2012
ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT
K112600 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 145d
Cleared Jan 30, 2012
MCKESSON HORIZON CARDIOLOGY
K112720 · LLZ
Mckesson Israel , Ltd.
Radiology · 133d
Cleared Jan 30, 2012
ALDAHOL V HIGH LEVEL DISINFECTANT
K113015 · MED
Microchem Laboratories, Inc.
General Hospital · 111d
Cleared Jan 30, 2012
MAXLOCK EXTREME SYSTEM
K113048 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 110d
Cleared Jan 30, 2012
CAAS A-VALVE
K113076 · LLZ
Pie Medical Imaging BV
Radiology · 105d
Cleared Jan 30, 2012
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
K113555 · NGT
Am USA
General Hospital · 60d
Cleared Jan 30, 2012
GLUCOSE METER-CHECK SOLUTION FOR INFOPIA
K113764 · JJX
Bionostics, Inc.
Chemistry · 40d
Cleared Jan 27, 2012
MICRODOT & MICRODOT XTRA
K102383 · NBW
Cambridge Sensors Limited
Chemistry · 522d
Cleared Jan 27, 2012
SANTORINI SPINAL SYSTEM
K111294 · MQP
K2m, Inc.
Orthopedic · 262d
Cleared Jan 27, 2012
NEUMOVENT GRAPHNET
K111595 · CBK
Tecme S.A.
Anesthesiology · 234d
Cleared Jan 27, 2012
BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE
K112233 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 176d
Cleared Jan 27, 2012
ELECTRO-CAP SYSTEM
K112319 · GXY
Electro-Cap Intl., Inc.
Neurology · 169d
Cleared Jan 27, 2012
FINGERTIP PULSE OXIMETER
K112804 · DQA
Guangdong Biolight Meditech Co., Ltd.
Anesthesiology · 122d
Cleared Jan 27, 2012
BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS
K112875 · DZE
Blue Sky Bio, LLC
Dental · 119d
Cleared Jan 27, 2012
REST ASSURED READY TO WEAR NITE PROTECTOR
K112879 · OBR
Ranir, LLC
Dental · 119d
Cleared Jan 27, 2012
SOCKET GRAFT
K113049 · LYC
Steiner Laboratories
Dental · 106d
Cleared Jan 27, 2012
MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1
K113141 · FLL
Microlife Intellectual Property GmbH
General Hospital · 95d
Cleared Jan 27, 2012
MODEL HBP-1300
K113185 · DXN
Omron Healthcare, Inc.
Cardiovascular · 91d
Cleared Jan 27, 2012
SPOTLIGHT ACCESS SYSTEM
K113273 · GZT
Johnson & Johnson
Neurology · 81d
Cleared Jan 27, 2012
VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM
K113486 · IYO
Volcano Corporation
Radiology · 65d
Cleared Jan 27, 2012
PATHASSIST LIGHT SEEKER
K113522 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 59d
Cleared Jan 27, 2012
VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT
K113524 · JJX
Maine Standards Co.
Chemistry · 59d
Cleared Jan 27, 2012
GMK RESUFACING PATELLA SIZE 4
K113571 · JWH
Medacta International
Orthopedic · 56d