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
144505–144528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 1986
YEAST IDENTIFICATION PANEL
K860575 · JXB
American Micro Scan
Microbiology · 84d
Cleared May 13, 1986
DIRECTIGEN COMBO MENINGITIS TEST
K860768 · GTZ
Bd Becton Dickinson Vacutainer...
Microbiology · 71d
Cleared May 13, 1986
LEECO-SCREEN, STREP A (EIA)
K860947 · GTZ
Leeco Diagnostics, Inc.
Microbiology · 62d
Cleared May 13, 1986
ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY
K860990 · FGE
Endovations
Gastroenterology & Urology · 57d
Cleared May 13, 1986
LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO
K861440 · DTB
Pacesetter Systems
Cardiovascular · 26d
Cleared May 13, 1986
ALISUN -TYPE 1200, TYPE 1000/800 AND TYPE 700/900
K861447 · FTC
Southern Exposure, Inc.
General & Plastic Surgery · 26d
Cleared May 13, 1986
MONOSTAR SYSTEM: IM LATEX TEST
K861452 · KTN
U.S. Health Resources Corp.
Immunology · 25d
Cleared May 13, 1986
ALPHA TAN 1000 AND ALPHA TAN 1200
K861570 · FTC
Midwest Marketing Service
General & Plastic Surgery · 15d
Cleared May 13, 1986
ULTRACLONE 01-2300 CELL LINE
K861585 · KIR
Earl-Clay Laboratories, Inc.
Pathology · 14d
Cleared May 13, 1986
VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET
K861745 · DWS
Keeler Instruments, Inc.
Cardiovascular · 7d
Cleared May 12, 1986
MONARCH II BLEACHING INSTRUMENT
K854692 · EEG
Almore Intl., Inc.
Dental · 172d
Cleared May 12, 1986
DENCLENZ
K854995 · EFT
Creighton Products Corp.
Dental · 151d
Cleared May 12, 1986
OSCILLOMATE NEONATAL BLOOD PRESS. MONIT.-MODEL 901
K860196 · DXN
Cas Medical Systems, Inc.
Cardiovascular · 110d
Cleared May 12, 1986
ISO-THERMEX
K861100 · FLL
Columbus Instruments Intl. Corp.
General Hospital · 49d
Cleared May 12, 1986
CASTALERT
K861292
Walgen Medical Innoventions
Orthopedic · 35d
Cleared May 12, 1986
CHURCHILL INJECTION SITE
K861430 · FPA
Churchill Corp.
General Hospital · 26d
Cleared May 12, 1986
TECNOL PERSONAL SHOE COVER
K861528 · FXP
Technol, Inc.
General Hospital · 18d
Cleared May 12, 1986
MEDIPOINT MULTI-SAMPLE BLOOD COLLECTING NEEDLE
K861560 · FMI
Medi Point, Inc.
General Hospital · 17d
Cleared May 12, 1986
SLR BIPOLAR HIP ENDOPROSTHESIS
K861566 · KWY
Dow Corning Wright
Orthopedic · 17d
Cleared May 12, 1986
SHORTENING OSTEOTOMY GUIDE
K861576 · HTH
Osteotomy Guide Co.
Orthopedic · 14d
Cleared May 12, 1986
CENTRIX PCR MOLAR MATRIX FORMS (BANDS)
K861581 · DZN
Centrix, Inc.
Dental · 13d
Cleared May 12, 1986
TOPICAL HYPERBARIC OXYGEN CHAMBER
K861593 · KPJ
Stephenson Industries, Inc.
General & Plastic Surgery · 13d
Cleared May 12, 1986
SPUNGUARD PLUS SURGICAL GOWN
K861600 · FYA
Kimberly-Clark Corp.
General Hospital · 13d
Cleared May 09, 1986
VICKERS MEDICAL MODEL 271 HEART RATE MONITOR
K854597 · DRT
Vickers , Ltd.
Cardiovascular · 172d