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
47689–47712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 2011
TRIXEL CO2 LASER
K110434 · GEX
Beijing Syntech Laser Co., Ltd.
General & Plastic Surgery · 63d
Cleared Apr 19, 2011
FLEXIBLE CARDIAC COIL
K110487 · MOS
Lbds Holding Company
Radiology · 56d
Cleared Apr 19, 2011
EVERON CENTRAL DISPLAY STATION (CDS)
K110521 · MSX
Earlysense, Ltd.
Cardiovascular · 55d
Cleared Apr 19, 2011
SPACELABS SMART DISCLOSURE SYSTEM
K110779 · DQK
Spacelabs Healthcare
Cardiovascular · 29d
Cleared Apr 19, 2011
PARIETEX OPTIMIZED COMPOSTIE MESH
K110815 · FTL
Sofradim Production
General & Plastic Surgery · 26d
Cleared Apr 19, 2011
PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)
K110816 · FTL
Sofradim Production
General & Plastic Surgery · 26d
Cleared Apr 18, 2011
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7...
K100344 · MOI
Siemens Healthcare Diagnostics
Immunology · 437d
Cleared Apr 18, 2011
AOI CRANIAL HELMET
K103362 · MVA
Advanced Orthopro, Inc.
Neurology · 152d
Cleared Apr 18, 2011
INFILL INTERVERTEBRAL BODY FUSION DEVICE
K103729 · MAX
Pinnacle Spine Group, LLC
Orthopedic · 117d
Cleared Apr 18, 2011
RESPICHAMBER VALVED HOLDING CHAMBER
K110136 · NVP
Trudell Medical Intl.
Anesthesiology · 90d
Cleared Apr 15, 2011
MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER
K100183 · MNW
Tanita Corp.
Gastroenterology & Urology · 449d
Cleared Apr 15, 2011
REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM
K102418 · DQY
Reverse Medical Corporation
Cardiovascular · 233d
Cleared Apr 15, 2011
ATMOS E 201 THORAX AND ATMOS S 201 THORAX
K103042 · BTA
Atmos, Inc.
General & Plastic Surgery · 183d
Cleared Apr 15, 2011
LANX SPINAL FIXATION SYSTEM
K103091 · KWP
Lanx, Inc.
Orthopedic · 178d
Cleared Apr 15, 2011
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR...
K103524 · FPL
International Biomedical, Ltd.
General Hospital · 135d
Cleared Apr 15, 2011
AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR...
K103527 · FPL
International Biomedical, Ltd.
General Hospital · 135d
Cleared Apr 15, 2011
ARTISTE SOLUTION WITH SYS_VB50 UPDATE
K103606 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 127d
Cleared Apr 15, 2011
CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS
K103662 · LPH
Zimmer, Inc.
Orthopedic · 121d
Cleared Apr 15, 2011
SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS
K110152 · JOJ
Spsmedical Supply Corp.
General Hospital · 86d
Cleared Apr 15, 2011
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K110767 · PNO
Angioscore, Inc.
Cardiovascular · 28d
Cleared Apr 15, 2011
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED...
K110841 · IYN
Shantou Institute of Ultrasonic...
Radiology · 21d
Cleared Apr 15, 2011
NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K110921 · LZA
Cardinal Health, Inc.
General Hospital · 14d
Cleared Apr 14, 2011
NEWDEAL COMPRESSION PLATES
K093914 · HRS
Newdeal Sas
Orthopedic · 478d
Cleared Apr 14, 2011
3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M...
K101468 · FYA
3M Company Corp
General Hospital · 322d