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
158641–158664 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1983
TOOTH CONDITIONER
K823928 · DYH
Dentsply Intl.
Dental · 28d
Cleared Jan 26, 1983
KARICKHOFF KERATOSCOPE
K830008 · HLR
Surgidev Corp.
Ophthalmic · 23d
Cleared Jan 26, 1983
SUPERJET LANCET
K830010 · FMK
Medprobe Laboratories
General & Plastic Surgery
Cleared Jan 26, 1983
VOLUMETRIC PUMP ADMIN. SETS
K830017 · FRN
Travenol Laboratories, S.A.
General Hospital · 23d
Cleared Jan 26, 1983
SAFE-T ARM BOARD
K830018 · BTX
Harvey A. Turner, M.D.
General & Plastic Surgery · 23d
Cleared Jan 26, 1983
SIGMA 7000-6000 INFUSION PUMPS
K830038 · FRN
Sigma
General Hospital · 8d
Cleared Jan 26, 1983
E-Z JECTOR
K830042 · EJI
Innovators, Inc.
Dental · 19d
Cleared Jan 26, 1983
MOLNLYCKE MESALT STERILE DRESSING
K830051 · FRO
Lada Intl., Inc.
General & Plastic Surgery · 16d
Cleared Jan 26, 1983
20 MICRON HIGH CAPACITY TRANS/FILTER
K830057 · CAK
Travenol Laboratories, S.A.
General Hospital · 19d
Cleared Jan 24, 1983
PERCOR INTRA-AORTIC BALLOON INSERTION
K823342 · DSP
Datascope Corp.
Cardiovascular · 77d
Cleared Jan 24, 1983
ZIMMER GREAT TOE
K823405 · KWH
Zimmer, Inc.
Orthopedic · 70d
Cleared Jan 24, 1983
GENESIS B-HCG
K823753 · JHI
Armkel, LLC
Chemistry · 41d
Cleared Jan 24, 1983
MEDELA NAMUAL BREAST PUMP
K823840 · HGY
Medela, Inc.
Obstetrics & Gynecology · 34d
Cleared Jan 24, 1983
URIC ACID TEST
K823846 · KNK
Scalavo, Inc.
Chemistry · 34d
Cleared Jan 24, 1983
VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER
K827577
Randwal Instrument Co., Inc.
Radiology · 35d
Cleared Jan 24, 1983
MEDELA SUCTION PUMP
K830012 · HDB
Medela, Inc.
Obstetrics & Gynecology · 21d
Cleared Jan 24, 1983
TRACTION 230
K830088 · ITH
Tri W-G, Inc.
Physical Medicine · 13d
Cleared Jan 24, 1983
MODEL ML-4000 OPHTHALMIC LASER WITH FIBER OPTIC DELIVERY SYSTEM
K837030
Meditec, Inc.
Radiology · 35d
Cleared Jan 21, 1983
LATEX PENROSE TUBING
K822755
American Hospital Supply Corp.
General & Plastic Surgery · 135d
Cleared Jan 21, 1983
KF-E SERIES HOLLOW FIBER DIALYZER
K823069 · KOC
Medisystems Corp.
Gastroenterology & Urology · 94d
Cleared Jan 21, 1983
BERKELEY CHAIR
K823085 · ITI
Berkeley Electric Wheelchair Co.
Physical Medicine · 94d
Cleared Jan 21, 1983
RCI EARMATE
K823089 · ESD
Rci, Inc.
Ear, Nose, Throat · 94d
Cleared Jan 21, 1983
SKIN GALVANOMETER
K823194 · HCJ
Spelson Research Laboratories, Inc.
Neurology · 87d
Cleared Jan 21, 1983
BACK ON TRACK INVERSION THERAPY & EXER
K823236 · ION
Lossing Orthopedic, Inc.
Physical Medicine · 81d