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
167233–167256 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 1980
LIFELINE TLE J-SHAPED ATRIAL ENDOCARDIAL
K792301 · DTB
Intermedics, Inc.
Cardiovascular · 202d
Cleared Jun 04, 1980
SUN SCENE TAN BOOTH
K800592
Sun Scene International, Inc.
Radiology · 79d
Cleared Jun 04, 1980
A-GENT QUANTICHROM THROMBIGEN I
K800725 · GGW
Abbott Laboratories
Hematology · 64d
Cleared Jun 04, 1980
SUNTANA SUNBED #SB-1 & SUNBRELLA #SU-1
K800744 · LEJ
Sun Ind., Inc.
Radiology · 62d
Cleared Jun 04, 1980
OMNITON MT80-A BODY HEARING AID
K800779 · ESD
Bosch Hearing Instruments, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 04, 1980
ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN.
K800838 · DXY
Arco Medical Products Co.
Cardiovascular · 50d
Cleared Jun 04, 1980
TONOTEST BLOOD PRESSURE MONITOR
K800904 · DXN
Retlif, Inc.
Cardiovascular · 44d
Cleared Jun 04, 1980
AUDIONICS PB MAX HEARING AID
K800940 · ESD
Audionics Corp.
Ear, Nose, Throat · 43d
Cleared Jun 04, 1980
TANIT HOME SUNTANNING UNIT
K800950 · FTC
Tanit, Inc.
Radiology · 42d
Cleared Jun 04, 1980
HOWMEDICA WHITE C&B ALLOY
K801009 · EJS
Dental Laboratory Products Div.
Dental · 37d
Cleared Jun 04, 1980
SURGICAL MASK
K801036 · FXX
American Threshold Industries, Inc.
General Hospital · 33d
Cleared Jun 04, 1980
PULSED GALVANIC STIMULATOR, 450-DYNAMAX
K801053 · IPF
U.S. Medical Corp.
Physical Medicine · 30d
Cleared Jun 04, 1980
EDP 1200 ULTRASONIC B-SCANNER
K801056 · IYO
Technicare Corp.
Radiology · 29d
Cleared Jun 04, 1980
HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE
K801060 · IYO
Smithkline Diagnostics, Inc.
Radiology · 29d
Cleared Jun 04, 1980
BEHIND-THE-EAR HEARING AID SERIES G
K801062 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 29d
Cleared Jun 04, 1980
PERFECTEMP OPHTHALMIC CAUTERY
K801078 · HQP
Medical Products Development, Inc.
Ophthalmic · 28d
Cleared Jun 04, 1980
SAMPLING KIT
K801146 · CBT
Pharmaseal Laboratories
Anesthesiology · 22d
Cleared Jun 04, 1980
PEDIATRIC ARTERIAL BLOOD FILTER #AF-5
K801147 · DTM
Bentley Laboratories, Inc.
Cardiovascular · 22d
Cleared Jun 04, 1980
CONPHAR WALL MODEL MERCURY SPHYGMOMAN.
K801182 · DXQ
Conphar, Inc.
Cardiovascular · 19d
Cleared Jun 04, 1980
CONPHAR DUAL HEAD STETHOSCOPE
K801183 · LDE
Conphar, Inc.
Cardiovascular · 19d
Cleared Jun 04, 1980
CONPHAR SPRAGUE RAPPAPORT STETHOSCOPE
K801184 · LDE
Conphar, Inc.
Cardiovascular · 19d
Cleared Jun 04, 1980
CONPHAR BOWLS STETHOSCOPE
K801185 · LDE
Conphar, Inc.
Cardiovascular · 16d
Cleared Jun 04, 1980
CONPHAR SUPERTONE STETHOSCOPE
K801189 · DQD
Conphar, Inc.
Cardiovascular · 16d
Cleared Jun 04, 1980
VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EX
K801199 · BWF
Chesebrough-Pond'S U.S.A. Co.
Anesthesiology · 16d