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

Filters: Cleared only ×
175,820 results
146905–146928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 1985
FREEDOM LINE LUBRICATED MODELS LS-2-5, LT-6-10
K852816 · EIA
Apollo Dental Products, Inc.
Dental · 114d
Cleared Oct 24, 1985
ACUSON RADIOLOGY DOPPLER ACCESSORY
K852974 · ITX
Acuson Computed Sonography
Radiology · 101d
Cleared Oct 24, 1985
LIFELINE ENDOCARDIAL BIPOLAR LEAD 484-03
K853519 · DTB
Intermedics, Inc.
Cardiovascular · 63d
Cleared Oct 24, 1985
TOP SUN MODELS 100,101,103 &139, 139-1, 139-3
K853833 · FTC
Top Sun America, Inc.
General & Plastic Surgery · 38d
Cleared Oct 24, 1985
CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105
K853861 · IJZ
Canon USA, Inc.
Radiology · 37d
Cleared Oct 23, 1985
MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417
K850165 · JOP
Hoffrel Instruments, Inc.
Cardiovascular · 280d
Cleared Oct 23, 1985
COMPANION 2800 VOLUME VENTILATOR
K851366
Puritan Bennett Corp.
Cardiovascular · 201d
Cleared Oct 23, 1985
CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY
K851889 · BZQ
Clinical Data, Inc.
Anesthesiology · 176d
Cleared Oct 23, 1985
750 SD ULTRASOUND SCANNER(MODIFICATION)
K851901 · DXK
Ultrasonix, Inc.
Cardiovascular · 176d
Cleared Oct 23, 1985
OCS-2 COLPOSCOPE
K852980 · HEX
Olympus Corp.
Obstetrics & Gynecology · 100d
Cleared Oct 23, 1985
E-Z-GUARD MOUTHPIECE
K853402 · BYP
E-Z-Em, Inc.
Anesthesiology · 72d
Cleared Oct 23, 1985
COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI
K853590 · DXY
Cook Pacemaker Corp.
Cardiovascular · 56d
Cleared Oct 23, 1985
COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER
K853651 · DXY
Cook Pacemaker Corp.
Cardiovascular · 50d
Cleared Oct 23, 1985
VEDLAR VENTILATOR (MODIFICATION)
K854026
Hamilton Medical, Inc.
Cardiovascular · 58d
Cleared Oct 23, 1985
MANUAL VENTILATION ACCESSORY
K854036
Siemens Elema AB
Cardiovascular · 57d
Cleared Oct 23, 1985
SYVA MYCOTRANS MYCOPLASMA TRANSPORT SYSTEM
K854061 · JSM
Syva Co.
Microbiology · 19d
Cleared Oct 23, 1985
BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR
K854064 · KZI
Bd Becton Dickinson Vacutainer...
Microbiology · 19d
Cleared Oct 23, 1985
TSK STERIJECT STERILE EPIDURAL NEEDLE
K854149 · BSP
Pharmacia, Inc.
Anesthesiology · 12d
Cleared Oct 23, 1985
PHADIRECT STREP A TEST
K854150 · GTZ
Pharmacia, Inc.
Microbiology · 12d
Cleared Oct 22, 1985
EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE
K852392 · CGS
Helena Laboratories
Chemistry · 139d
Cleared Oct 22, 1985
#9431 TELETRACE, TELEPHONE, EKG TRANSMITTER
K852971 · DXH
Medtronic Vascular
Cardiovascular · 99d
Cleared Oct 22, 1985
FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT
K853067 · GRE
Idt, A Division of Whittaker M.A....
Microbiology · 92d
Cleared Oct 22, 1985
XYLENE SUBSTITUTE
K853694 · KEM
Lerner Laboratories, Inc.
Pathology · 48d
Cleared Oct 22, 1985
GRAM STAIN KIT
K853896 · JTS
Sigma Diagnostics, Inc.
Pathology · 32d