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
168217–168240 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 1980
MICROTHIN-PI
K800027 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 24d
Cleared Jan 31, 1980
H-H FIFTH VENTRICLE
K800168 · JXG
Holter-Hausner Intl.
Neurology · 6d
Cleared Jan 29, 1980
M.P.I. LENS GLIDE
K792066 · KYB
J. Leon Bilby
Ophthalmic · 106d
Cleared Jan 29, 1980
COULTER COUNTER MODEL S PLUS
K792537 · GKL
Coulter Electronics, Inc.
Hematology · 50d
Cleared Jan 29, 1980
URIC ACID KIT
K792545 · KNK
Alta Diagnostics, Inc.
Chemistry · 50d
Cleared Jan 29, 1980
AGAROSE BARBITAL BUFFER
K792547 · JJN
Electrophoresis Corp. of America
Chemistry · 50d
Cleared Jan 29, 1980
ALKALINE PHOSPHATASE MARKER
K792548 · CIN
Electrophoresis Corp. of America
Chemistry · 50d
Cleared Jan 29, 1980
ALKALINE PHOSPHATASE REAGENT
K792551 · CJH
Electrophoresis Corp. of America
Chemistry · 50d
Cleared Jan 29, 1980
AGAROSE BARBITAL-EDTA BUFFER
K792553 · JJN
Electrophoresis Corp. of America
Chemistry · 50d
Cleared Jan 29, 1980
UNISPORE-BIOLOGICAL INDICATORS
K792649 · FRC
Castle Co.
General Hospital · 39d
Cleared Jan 29, 1980
1500 EO EXHAUST HOOD
K792660 · FLF
Castle Co.
General Hospital · 33d
Cleared Jan 29, 1980
PIXIE
K792665 · IZL
Porta Ray, Inc.
Radiology · 33d
Cleared Jan 29, 1980
COULTER COUNTER-BLOOD CELL COUNTER
K792668 · GKL
Coulter Electronics, Inc.
Hematology · 33d
Cleared Jan 29, 1980
RIONET HEARING AID HE-71
K800011 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jan 29, 1980
RIONET HEARING AID HA-61
K800012 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jan 29, 1980
I.V. TAPE DOWN HOLDER
K800024 · KMK
Consolidated Medical Equipment, Inc.
General Hospital · 22d
Cleared Jan 29, 1980
LDC CONSTAMETRIC III HIGHT PRESS. SOL.
K800048 · KIE
Laboratory Data Control
Toxicology · 20d
Cleared Jan 29, 1980
H-I-M-TEST FOR DETECTING HUMAN CHOR. GON
K800055 · JHJ
Technam, Inc.
Chemistry · 19d
Cleared Jan 29, 1980
RITTER MODEL J DENTAL CHAIR
K800084 · KLC
Ritter Co.
Dental · 15d
Cleared Jan 29, 1980
PACEMAKER ELECTRODE INSERTER AIDE
K800088 · DTE
Telectronics, Inc.
Cardiovascular · 15d
Cleared Jan 28, 1980
HILO TRANS-X TRAUMA TRANSPORT
K792326 · IXR
Tecnomed, Inc.
Radiology · 70d
Cleared Jan 28, 1980
PORTARAY
K792535 · EAP
Siemens Corp.
Radiology · 52d
Cleared Jan 28, 1980
OBSTETRICAL BEDS
K792568 · KNC
Ets Rene Marzet
Obstetrics & Gynecology · 46d
Cleared Jan 28, 1980
COMPUTED TOMOGRAPHY X-RAY SCANNER
K792603 · JAK
Ohio Nuclear, Inc.
Radiology · 41d