FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

Filters: Cleared only ×
175,230 results
38281–38304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 2014
M SERIES PATIENT MONITOR
K131876 · MHX
Mid-Link Consulting Co, Ltd.
Cardiovascular · 248d
Cleared Feb 27, 2014
U&U STERILE PISTON SYRINGE WITHOUT NEEDLE
K132553 · FMF
U&U Medical Technology Co, Ltd.
General Hospital · 197d
Cleared Feb 27, 2014
SARNS SOFT-FLOW EXTENDED AORTIC CANNULA
K132811 · DWF
Terumo Cardiovascular Systems...
Cardiovascular · 171d
Cleared Feb 27, 2014
MADSEN ACCUSCREEN TYPE 1077
K132957 · GWJ
Gn Otometrics
Neurology · 160d
Cleared Feb 27, 2014
COMPACT INTUITIV
K133115 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 150d
Cleared Feb 27, 2014
EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM
K133647 · NBW
Eps Bio Technology Corp.
Chemistry · 92d
Cleared Feb 27, 2014
SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM
K133773 · JWY
Thermo Fisher Scientific
Microbiology · 77d
Cleared Feb 27, 2014
ARTHREX IBALANCE TKA SYSTEM
K133854 · JWH
Arthrex, Inc.
Orthopedic · 70d
Cleared Feb 27, 2014
TARGET3D FUSION
K140033 · LLZ
Convergent Life Sciences, Inc.
Radiology · 51d
Cleared Feb 27, 2014
ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
K140178 · PGN
Ellipse Technologies, Inc.
Orthopedic · 34d
Cleared Feb 26, 2014
U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL
K123162 · FRG
U&U Medical Technology Co, Ltd.
General Hospital · 505d
Cleared Feb 26, 2014
TRINIAS
K123508 · OWB
Shimadzu Corporation
Radiology · 470d
Cleared Feb 26, 2014
STATUS DS OXY
K130650 · DJG
Princeton BioMeditech Corp.
Toxicology · 352d
Cleared Feb 26, 2014
ANAL RECTAL OVERTUBE
K131598 · FED
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 268d
Cleared Feb 26, 2014
EXCELERON BACTERIAL FILTERS
K131626 · CAH
Exceleron Medical
General Hospital · 267d
Cleared Feb 26, 2014
PRESSURE CONNECTING TUBE
K131770 · DQO
Shenzhen Ant Hi-Tech Industrial Co.,...
Cardiovascular · 254d
Cleared Feb 26, 2014
IFA 40: HEP-20-10
K131791 · DHN
Euroimmun US
Immunology · 253d
Cleared Feb 26, 2014
ARTHROSURFACE TOEMOTION
K132496 · LZJ
Arthrosurface, Inc.
Orthopedic · 201d
Cleared Feb 26, 2014
FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED...
K132889 · JAQ
Nucletron B.V.
Radiology · 163d
Cleared Feb 26, 2014
OSI Q SYSTEM ARTHROSCOPES
K133018 · HRX
Orthopedic Sciences, Inc.
Orthopedic · 154d
Cleared Feb 26, 2014
LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE
K133385 · LLZ
Broncus Medical, Inc.
Radiology · 113d
Cleared Feb 26, 2014
NEMUS 2 SYSTEM
K133517 · GWL
Eb Neuro S.P.A.
Neurology · 103d
Cleared Feb 26, 2014
EMERGE MEDICAL BONE PLATE SYSTEM
K133536 · HRS
Emerge Medical
Orthopedic · 100d
Cleared Feb 26, 2014
SUREFIRE GUIDING CATHETER
K140034 · DQY
Surefire Medical, Inc.
Cardiovascular · 50d