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
151465–151488 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1984
TRENDS LANCET
K843882 · KMK
Orange Medical Instruments, Inc.
General Hospital · 34d
Cleared Nov 05, 1984
SNYDER HEMOVAC WOUND DRAINAGE DEVICES
K843906 · GBS
Snyder Laboratories, Inc.
General & Plastic Surgery · 33d
Cleared Nov 05, 1984
GILL'S IRRIGATOR/ASPIRATOR NEEDLE
K843925 · GAA
Concept, Inc.
General & Plastic Surgery · 31d
Cleared Nov 05, 1984
SUSPENSION 7
K843985
Cgr Medical Corp.
Radiology · 25d
Cleared Nov 05, 1984
AZTECH INDUSTRIES SUNTANNING BED AZ100
K844039 · FTC
Aztech Industries, Inc.
General & Plastic Surgery · 20d
Cleared Nov 05, 1984
DERMIZIP SKIN CLOSURE DEVICE
K844072
Kells Medical, Inc.
General & Plastic Surgery · 18d
Cleared Nov 02, 1984
TEMPTREND PEDS AXILLARY TEMP. INDICATOR
K841913 · KPD
Biosynergy, Inc.
General Hospital · 177d
Cleared Nov 02, 1984
I.V. TEAMATE
K842479 · FRN
Medical Delivery Systems
General Hospital · 130d
Cleared Nov 02, 1984
ABBOTT HTSH EIA DIAGNOSTIC KIT
K843540 · JLW
Abbott Laboratories
Chemistry · 56d
Cleared Nov 02, 1984
VITAJET JET INSULIN INJECTION DEVICE
K843784 · KZE
Vitajet Industriae Comercioltda.
General Hospital · 37d
Cleared Nov 02, 1984
HDL PRECIPATATING REAGENT SET
K843894 · LBR
Livonia Diagnostics, Inc.
Chemistry · 30d
Cleared Nov 01, 1984
PERICARDIAL PATCH
K833763 · DXZ
American Edwards Laboratories
Cardiovascular · 372d
Cleared Nov 01, 1984
AUTOFLOUR III SYSTEM
K841984 · DHN
Tech America Diagnostics
Immunology · 170d
Cleared Nov 01, 1984
SUN-ONE
K842048 · BZQ
Ensun Medical Products, Inc.
Anesthesiology · 163d
Cleared Nov 01, 1984
PHARMACIA B2-MICRO RIA
K842772 · JGZ
Pharmacia, Inc.
Immunology · 108d
Cleared Nov 01, 1984
TERM GUARD 5000 UTERINE ACTIVITY
K843011 · HFM
Tokos Medical Corp.
Obstetrics & Gynecology · 93d
Cleared Nov 01, 1984
COLORZYME NDNA TEST SYSTEM
K843225 · DHN
Immuno Concepts, Inc.
Immunology · 77d
Cleared Nov 01, 1984
MICROPROCESSOR 7200A VENTILATOR
K843424 · CBK
Puritan Bennett Corp.
Anesthesiology · 62d
Cleared Nov 01, 1984
AW TEST
K843848 · BZC
Erich Jaeger, Inc.
Anesthesiology · 31d
Cleared Nov 01, 1984
APTA-BRONCHOSCREEN
K843852 · BZC
Erich Jaeger, Inc.
Anesthesiology · 31d
Cleared Nov 01, 1984
DNA STAT TEST KIT
K843904 · LJM
Whittaker Bioproducts, Inc.
Immunology · 29d
Cleared Nov 01, 1984
IN THE CANAL HEARING AID RC, REDICANAL
K843921 · ESD
Omni Hearing Systems
Ear, Nose, Throat · 27d
Cleared Nov 01, 1984
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
K843962 · JPK
R&D Systems, Inc.
Hematology · 21d
Cleared Oct 31, 1984
MEDICAL TAPE
K840446 · KGX
Lectec Corp.
General & Plastic Surgery · 273d