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
140449–140472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 1987
PT HEPARIN ADSORBENT
K870771 · JPA
Probe-Tek, Inc.
Hematology · 56d
Cleared Apr 23, 1987
PROTEIN S CONTROL PLASMA
K870917 · GGP
American Bioproducts Co.
Hematology · 48d
Cleared Apr 23, 1987
(I) LV AND (II) HV SERIES CANNULA
K871043 · GEA
Celebration Medical Products, Inc.
General & Plastic Surgery · 37d
Cleared Apr 23, 1987
FOUNDATIONS PLUS ABDOMINAL BAND 1100
K871138
Foundations Plus, Inc.
General & Plastic Surgery · 31d
Cleared Apr 23, 1987
PACE 10 NON-INVASIVE EXTERNAL PACEMAKER
K871176 · DRO
Medac, Inc.
Cardiovascular · 30d
Cleared Apr 23, 1987
SUN CAPSULE I & II SUNTANNING BOOTH
K871237 · FTC
Sun Capsule, Inc.
General & Plastic Surgery · 27d
Cleared Apr 23, 1987
EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93
K871414 · JMO
Em Diagnostic Systems, Inc.
Chemistry · 15d
Cleared Apr 22, 1987
MATRIX LD & LD/LASER DIGITIZER
K860777 · LMA
Matrix Instruments
Radiology · 415d
Cleared Apr 22, 1987
THE FM-212A BIOFEEDBACK UNIT
K861950 · HCC
Hosa Technology, Inc.
Neurology · 337d
Cleared Apr 22, 1987
ENZYGNOST ANTI-VZV IGG TEST
K863317 · GQX
Behring Diagnostics, Inc.
Microbiology · 239d
Cleared Apr 22, 1987
EMT-102 CARDIAC MONITOR
K870049 · DXN
Evergreen Medical Technologies, Inc.
Cardiovascular · 106d
Cleared Apr 22, 1987
PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR
K870142 · DXY
Cardio-Pace Medical, Inc.
Cardiovascular · 99d
Cleared Apr 22, 1987
SPECTACLE FRAMES VARIOUS COLORS AND DESIGNS
K870179 · HQZ
Polinelli
Ophthalmic · 97d
Cleared Apr 22, 1987
BIOMEK 1000 AUTOMATED LABORATORY WORK STATION
K870544 · JQW
Beckman Instruments, Inc.
Chemistry · 72d
Cleared Apr 22, 1987
T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT
K870573 · CDX
Cambridge Medical Technology
Chemistry · 71d
Cleared Apr 22, 1987
CHLORIDE TEST
K870630 · CHJ
Sclavo, Inc.
Chemistry · 68d
Cleared Apr 22, 1987
OMEGA T100
K870666 · GZJ
Henley Intl.
Neurology · 62d
Cleared Apr 22, 1987
OMEGA T200
K870667 · GZJ
Henley Intl.
Neurology · 62d
Cleared Apr 22, 1987
BACTIGEN SALMONELLA-SHIGELLA TEST
K870813 · GRM
Armkel, LLC
Microbiology · 50d
Cleared Apr 22, 1987
CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS
K870928 · CHH
Electro-Nucleonics Laboratories, Inc.
Chemistry · 44d
Cleared Apr 22, 1987
WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM
K870949 · LDM
Millipore Corp.
Chemistry · 43d
Cleared Apr 22, 1987
DISPOSABLE, PIN-CONN. POLYMER-GEL ELECT. FOR TENS
K871026 · GXY
Labeltape Meditect, Inc.
Neurology · 37d
Cleared Apr 22, 1987
ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER
K871140 · DYB
Aries Medical, Inc.
Cardiovascular · 30d
Cleared Apr 22, 1987
URESIL CAROTID ARTERY SIZERS
K871148 · DRE
Uresil Corp.
Cardiovascular · 30d