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
70273–70296 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 2004
FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)
K032667 · GEX
Focus Medical, LLC
General & Plastic Surgery · 148d
Cleared Jan 23, 2004
SONOSENS
K033193 · NKI
Friendly Sensors AG
Neurology · 113d
Cleared Jan 23, 2004
CARRARA PRESS SYSTEM
K033667 · EIH
Dentsply Intl.
Dental · 63d
Cleared Jan 23, 2004
PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM
K033686 · LJT
Smiths Medical MD, Inc.
General Hospital · 60d
Cleared Jan 23, 2004
ONE COAT SE BOND
K033760 · KLE
Coltene/Whaledent, Inc.
Dental · 52d
Cleared Jan 22, 2004
POSTERIOR CABLE SCREW
K022908 · MNI
Pioneer Surgical Technology
Orthopedic · 506d
Cleared Jan 22, 2004
MATCH MASTER LOW FUSION PORCELAIN
K024252 · EIH
Davis Schottlander & Davis, Ltd.
Dental · 395d
Cleared Jan 22, 2004
CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM
K030876 · ISA
Cynosure, Inc.
Physical Medicine · 308d
Cleared Jan 22, 2004
HERO 1, MODEL LY-ESB220
K031621 · IPL
Comfort Orthopedic Co., Ltd.
Physical Medicine · 244d
Cleared Jan 22, 2004
SPACER G TEMPORARY HIP PROSTHESIS
K031841 · KWL
Exactech, Inc.
Orthopedic · 220d
Cleared Jan 22, 2004
POWERSTAND STAND-UP WHEELCHAIR
K032101 · IPL
The Standing Co., Inc.
Physical Medicine · 198d
Cleared Jan 22, 2004
DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368
K032692 · JZG
Dako A/S
Immunology · 142d
Cleared Jan 22, 2004
SUNPEX TECHNOLOGIES MODEL SE03
K033019 · INI
Sunpex Technology Co., Ltd.
Physical Medicine · 118d
Cleared Jan 22, 2004
T.S. MEDICAL CIRCUMCISION CLAMP
K033403 · HFX
T.S. Medical
Obstetrics & Gynecology · 90d
Cleared Jan 22, 2004
HUBERPRO SAFETY HUBER INFUSION SET
K033515 · FPA
Command Medical Products
General Hospital · 77d
Cleared Jan 22, 2004
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR
K033835 · LYZ
Mdm Enterprise Corp.
General Hospital · 43d
Cleared Jan 22, 2004
N HIGH SENSITIVITY CRP
K033908 · NQD
Dade Behring, Inc.
Chemistry · 36d
Cleared Jan 22, 2004
MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST
K033982 · MMW
Vysis
Immunology · 30d
Cleared Jan 22, 2004
MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69
K033989 · DQY
Medtronic Inc. Cardiac Rhythm Management
Cardiovascular · 30d
Cleared Jan 22, 2004
MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET
K033991 · HIF
Pall Medical
Obstetrics & Gynecology · 30d
Cleared Jan 22, 2004
CA-1500
K040028 · LLZ
R2 Technology, Inc.
Radiology · 14d
Cleared Jan 21, 2004
LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001
K031321 · KMF
Medlogic Global Limited
General & Plastic Surgery · 271d
Cleared Jan 21, 2004
AEROMIST LT, MODEL HCS15004
K031686 · BTI
Medline Industries, Inc.
Anesthesiology · 233d
Cleared Jan 21, 2004
SK MED ME202 MONITORING MIXER
K031860 · BZR
Sk Med
Anesthesiology · 219d