FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
150745–150768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 24, 1984
PRESSURE TRANSDUCER DOME 1295C
K841613 · DRS
Hewlett-Packard Co.
Cardiovascular · 184d
Cleared Oct 24, 1984
MINGOGRAF 7
K841868 · DSH
Siemens Medical Solutions USA, Inc.
Cardiovascular · 173d
Cleared Oct 24, 1984
JIMMY JOHN III
K842083 · KPL
Colon Therapeutics
Gastroenterology & Urology · 154d
Cleared Oct 24, 1984
MD308H DIGITAL/MB351H AUTO-BP MONITOR
K842200 · DXN
Sharp Electronics Corp.
Cardiovascular · 142d
Cleared Oct 24, 1984
HIP PROSTHESIS PACK
K842626
Deroyal Industries, Inc.
Orthopedic · 110d
Cleared Oct 24, 1984
DISPOSABLE PATIENT BLANKET
K843038 · KME
Anago, Inc.
General Hospital · 83d