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
149641–149664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 1985
KONTRON MINIMON 7131 PATIENT MONITOR
K844733 · DRT
Kontron Instruments, Inc.
Cardiovascular · 113d
Cleared Mar 27, 1985
POST-AURICULAR HEARING AID MODEL PE 600CHD
K844860 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 103d
Cleared Mar 27, 1985
POST-AURICULAR HEARING AID MODEL PE 600PPCL
K844861 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 103d
Cleared Mar 27, 1985
CORDIS ENCOR PERVENOUS ATRIAL & VENTRICULAR LEADS
K844970 · DTB
Cordis Corp.
Cardiovascular · 93d
Cleared Mar 27, 1985
MICRO VOLUME DOUBLE LINE EXTENSION SET
K850061 · FPA
Travenol Laboratories, S.A.
General Hospital · 78d
Cleared Mar 27, 1985
TISSUE TEMP PROBE
K850083 · FLL
Pat O. Daily
General Hospital · 76d
Cleared Mar 27, 1985
POST AURICULAR HEARING AIDS STAR 33PP, 44,55F &
K850186
Robert Bosch Corp.
Gastroenterology & Urology · 68d
Cleared Mar 27, 1985
ELECATH OPEN TIP BIPOLAR PACING CATHETER
K850324 · LDF
Electro-Catheter Corp.
Cardiovascular · 58d
Cleared Mar 27, 1985
NU-CATH EMERGENCY KIT
K850398 · FOZ
Intl. Medical Devices , Ltd.
General Hospital · 54d
Cleared Mar 27, 1985
ATS ACOUSTIC STANDOFF - WATER BAG
K850422 · ITX
Ats Laboratories, Inc.
Radiology · 51d
Cleared Mar 27, 1985
FLOSSAGE - ELECTRIC TOOTHFLOSSER
K850562 · JEQ
Mcspadden, Inc.
Dental · 43d
Cleared Mar 27, 1985
BLOOD OXYGENATOR MODEL NO. MAX-5
K850630 · DTZ
American Bentley
Cardiovascular · 36d
Cleared Mar 27, 1985
ACME LOW-PROFILE CHAIR SCAL 7300
K851014 · FRW
Acme Medical Scale Co.
General Hospital · 15d
Cleared Mar 26, 1985
EIGEN FLORO-STOR FS-100
K844375 · JAA
Eigen Video
Radiology · 133d
Cleared Mar 26, 1985
THROMBINEX BOVINE THROMBIN
K845000 · GJA
Bio/Data Corp.
Hematology · 90d
Cleared Mar 26, 1985
CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER
K845019 · GKL
Abbott Diagnostics
Hematology · 89d
Cleared Mar 26, 1985
MULTI-SIZE CASSETTE HOLDER
K850125 · IXY
Philips Medical Systems (Cleveland),...
Radiology · 71d
Cleared Mar 26, 1985
IRIDIUM 192 WIRES
K850163 · IWA
Syncor Intl. Corp.
Radiology · 69d
Cleared Mar 26, 1985
FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS
K850208 · IXD
Syncor Intl. Corp.
Radiology · 67d
Cleared Mar 26, 1985
API UNISCEPT KB
K850347 · LTW
Analytical Products, Inc.
Microbiology · 57d
Cleared Mar 26, 1985
ORBITOR II COUNTER BALANCE CAMERA
K850397 · IYX
Siemens Gammasonics, Inc.
Radiology · 53d
Cleared Mar 26, 1985
CS137 SEALED SOURCES
K850434 · KXK
Syncor Intl. Corp.
Radiology · 50d
Cleared Mar 26, 1985
I-125 IMPLANT GUN
K850571 · IWJ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 41d
Cleared Mar 26, 1985
SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY
K850614 · IZH
S & S X-Ray Products, Inc.
Radiology · 39d