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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
87529–87552 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1998
COMFEEL SEASORB DRESSING
K983519 · KMF
Coloplast Corp.
General & Plastic Surgery · 83d
Cleared Dec 30, 1998
SYSTEM U3 FOR TETRACYCLINE
K983571 · JWY
Ab Biodisk
Microbiology · 78d
Cleared Dec 30, 1998
BODYFORM THORACO-LUMBAR FIXATION SYSTEM
K983622 · KWQ
Theken Surgical,Llc
Orthopedic · 76d
Cleared Dec 30, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II
K983747 · DKB
Beckman Coulter, Inc.
Toxicology · 68d
Cleared Dec 30, 1998
AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5
K983761 · GEI
Aaron Medical Industries
General & Plastic Surgery · 65d
Cleared Dec 30, 1998
SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM
K983873 · KTT
Syntec Scientific Corp.
Orthopedic · 58d
Cleared Dec 30, 1998
METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM
K983976 · JDQ
Metagen, LLC
Orthopedic · 51d
Cleared Dec 30, 1998
ANTERIOR CERVICAL PLATING SYSTEM
K984342 · KWQ
United States Surgical, A Division of...
Orthopedic · 26d
Cleared Dec 30, 1998
DEPUY ACROMED MOSS SPINAL SYSTEM
K984378 · MNI
Depuy, Inc.
Orthopedic · 23d
Cleared Dec 30, 1998
NEUROMAG VECTORVIEW
K984401 · OLX
Philips Medical Systems (Cleveland),...
Neurology · 21d
Cleared Dec 30, 1998
XRE COLLIMATOR WITH SPECTRAL FILTER
K984414 · IZW
Trex Medical Corp.
Radiology · 20d
Cleared Dec 30, 1998
ULTIMA AIRFLOW PRESSURE SENSOR
K984431 · BZQ
Braebon Medical Corp.
Anesthesiology · 19d
Cleared Dec 29, 1998
VARIABLE PRESSURE SYRINGE PUMP
K974332 · FRN
Alaris Medical Systems, Inc.
General Hospital · 406d
Cleared Dec 29, 1998
CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER
K982337 · FJI
Haidylena Medical Egypt
Gastroenterology & Urology · 176d
Cleared Dec 29, 1998
THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE...
K983535 · JEY
Hans Hermann GmbH
Dental · 81d
Cleared Dec 29, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY
K983990 · CGR
Ortho-Clinical Diagnostics, Inc.
Chemistry · 50d
Cleared Dec 29, 1998
JELBOND NP
K984164 · EJH
Jelenko Co.
Dental · 39d
Cleared Dec 28, 1998
PULMOTRACK,MODEL 1010
K980878 · BZM
Karmel Medical Acoustic Technologies...
Anesthesiology · 294d
Cleared Dec 28, 1998
BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER
K982562 · HPZ
Integrated Orbital Implants, Inc.
Ophthalmic · 158d
Cleared Dec 28, 1998
DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE
K983484 · EGJ
Empi
Physical Medicine · 84d
Cleared Dec 28, 1998
AUTOSTAT II ENA SCREEN ELISA
K983921 · LLL
Cogent Diagnotics , Ltd.
Immunology · 54d
Cleared Dec 28, 1998
GREINER VACUETTE BLOOD COLLECTION TUBE
K983952 · JKA
Greiner Meditech, Inc.
Chemistry · 53d
Cleared Dec 28, 1998
PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION
K984535 · CBK
Puritan Bennett Corp.
Anesthesiology · 7d
Cleared Dec 24, 1998
BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR
K983559 · FJK
Icu Medical, Inc.
Gastroenterology & Urology · 72d