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
50545–50568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100733 · LYZ
Rayen Safety Products Limited
General Hospital · 46d
Cleared Apr 30, 2010
INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650
K100915 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 29d
Cleared Apr 30, 2010
ADMIRAL XTREME PTA BALLOON DILATATION CATHETER
K100921 · LIT
Invatec S.P.A.
Cardiovascular · 28d
Cleared Apr 30, 2010
PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J
K100930 · DQX
Volcano Corporation
Cardiovascular · 25d
Cleared Apr 30, 2010
INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50,...
K100939 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 25d
Cleared Apr 30, 2010
PRELOADED TISSUE MARKER DEVICE
K100994 · NEU
Carbon Medical Technologies, Inc.
General & Plastic Surgery · 21d
Cleared Apr 30, 2010
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
K101041 · ITX
Shenzhen Mindray Bio-Medical...
Radiology · 16d
Cleared Apr 29, 2010
DOPPLER FETAL HEARTBEAT RATE DETECTOR
K090510 · KNG
Shenzhen Bestman Instrument Co., Ltd.
Radiology · 427d
Cleared Apr 29, 2010
K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR
K091486 · DCF
Kamiya Biomedical Co.
Chemistry · 345d
Cleared CT Apr 29, 2010
STELLAR 300
K093017 · MWI
Larsen & Toubro Limited
Cardiovascular · 212d
Cleared Apr 29, 2010
VITAL SYNC MODEL 5000 SERIES
K093422 · MWI
Somanetics Corp.
Cardiovascular · 177d
Cleared Apr 29, 2010
BE MICRO, TREA
K093728 · OLV
Eb Neuro S.P.A.
Neurology · 147d
Cleared Apr 29, 2010
MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING
K093899 · KNW
Ethicon Endo-Surgery, LLC
Gastroenterology & Urology · 132d
Cleared Apr 29, 2010
ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL...
K100266 · MWJ
Camntech, Ltd.
Cardiovascular · 90d
Cleared Apr 29, 2010
OPAL BOND FLOW
K100301 · DYH
Ultradent Products, Inc.
Dental · 85d
Cleared Apr 29, 2010
INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX
K100517 · HDA
Instrumed International, Inc.
Obstetrics & Gynecology · 65d
Cleared Apr 28, 2010
SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901
K092611 · OQU
Sonarmed, Inc.
Anesthesiology · 245d
Cleared Apr 28, 2010
EPICAGE INTERBODY FUSION DEVICE
K092901 · MAX
R Tree Innovations
Orthopedic · 219d
Cleared Apr 28, 2010
ILLUMINA BEADXPRESS SYSTEM
K093128 · NSU
Illumina, Inc.
Hematology · 208d
Cleared CT Apr 28, 2010
ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II
K093129 · NPQ
Illumina, Inc.
Pathology · 208d
Cleared Apr 28, 2010
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
K093561 · LPH
Zimmer, Inc.
Orthopedic · 161d
Cleared Apr 28, 2010
EXTREMITY MEDICAL SCREW SYSTEM
K093770 · HWC
Extremity Medical, LLC
Orthopedic · 141d
Cleared Apr 28, 2010
ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200
K100258 · GEI
Wickimed Supply Limited
General & Plastic Surgery · 90d
Cleared Apr 28, 2010
MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R
K100319 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 83d