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

Filters: Cleared only ×
176,076 results
151585–151608 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 1984
HAYFEVER HELMET
K842973 · FRF
R.H. Hinchli Fle & Sons, Ltd.
General Hospital · 87d
Cleared Oct 25, 1984
KERR PORCELAIN REPAIR PRIMER
K843023 · KLE
Kerr Corporation (Danbury)
Dental · 85d
Cleared Oct 25, 1984
COMMAND ENAMEL-DENT DENTAL ADHESIVE
K843025 · KLE
Kerr Corporation (Danbury)
Dental · 85d
Cleared Oct 25, 1984
ANATOM SYSTEM
K843233 · KLC
Lic-Orthion
Dental · 69d
Cleared Oct 25, 1984
CITOMAT AUTOCLAVES
K843234 · ECG
Lic-Orthion
Dental · 69d
Cleared Oct 25, 1984
RESTODENT VL
K843363 · EBF
Lee Pharmaceuticals
Dental · 58d
Cleared Oct 25, 1984
VALVOTOMY KNIFE
K843371 · EMF
Downs Surgical , Ltd.
General & Plastic Surgery · 58d
Cleared Oct 25, 1984
MULTI-FORMAT FILM CAMERA
K843582 · LMC
Bfi- Medical Waste Systems
Radiology · 44d
Cleared Oct 25, 1984
THORA-KLEX AUTOTRANSFUSION KIT
K843586
C.R. Bard, Inc.
Cardiovascular · 44d
Cleared Oct 25, 1984
MTI 1200, 401 & 3500
K843647 · FTC
Manufactured Tan Intl.
General & Plastic Surgery · 37d
Cleared Oct 25, 1984
MYCOPLASMA PNEUMONIAE
K843664 · GSB
Institute Virion , Ltd.
Microbiology · 38d
Cleared Oct 25, 1984
ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE
K843690 · GDM
Popper & Sons, Inc.
General & Plastic Surgery · 36d
Cleared Oct 25, 1984
DISPOSABLE ISOLATION GOWN
K843721
Anago, Inc.
General & Plastic Surgery · 31d
Cleared Oct 25, 1984
NEMDI
K843734 · KCX
Nemectron Medical, Inc.
General & Plastic Surgery · 31d
Cleared Oct 25, 1984
SOFTEPIL
K843735 · KCX
Nemectron Medical, Inc.
General & Plastic Surgery · 31d
Cleared Oct 25, 1984
RPR TEST REDITEST
K843741 · GMP
Biokit USA, Inc.
Microbiology · 30d
Cleared Oct 25, 1984
ADP ANA APPLEZYME
K843745 · LJM
Apple Diagnostic Products
Immunology · 30d
Cleared Oct 25, 1984
MASON EQUIPMENT ORGANIZER & ASPEN
K843801 · FSE
Aspen Laboratories, Inc.
General & Plastic Surgery · 28d
Cleared Oct 25, 1984
EMUMOL ULTRAVIOLET SUNTANNING LAMP
K843814 · FTC
Mottek Intl. Corp.
General & Plastic Surgery · 27d
Cleared Oct 25, 1984
SCENTED BREATHABLE PRIVATE LABEL MINI-SH
K843886 · HHL
I.C.D. Industries, Inc.
Obstetrics & Gynecology · 23d
Cleared Oct 25, 1984
RHEUMADX LATEX AGGLUTINATION RHEUMATOID
K843896 · DHR
Diagnostic Products Corp.
Immunology · 22d
Cleared Oct 25, 1984
SERVO HUMIDIFIER 152 SIEMENS-ELEMA AB
K844040 · BYD
Siemens Elema AB
Anesthesiology · 9d
Cleared Oct 25, 1984
ESOPHAGEAL STETHO SCOPE
K844055 · BZT
Sensortek, Inc.
Anesthesiology · 7d
Cleared Oct 25, 1984
DIAGNOSTIC MICROSOPCE SLIDES
K844092
Sybron Corp.
Chemistry · 6d