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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
87025–87048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 24, 1998
UNIPOLAR OPTICAL BIOPSY FORCEPS
K983811 · KGE
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 57d
Cleared Dec 23, 1998
PROGUARD, RR-1, RR-2
K982832 · LZC
Emerson & Co. Srl
General Hospital · 133d
Cleared Dec 23, 1998
POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50...
K982897 · LYY
Pt. Maja Agung Latexindo
General Hospital · 128d
Cleared Dec 23, 1998
TRIP TONOMETRY CATHETER, 16F
K983366 · KNT
Datex-Engstrom, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 23, 1998
AGATHA-A-H2010
K983374 · EFS
Midian Intl.
Dental · 89d
Cleared Dec 23, 1998
SYSTEM U3 FOR NORFLOXACIN
K983486 · JWY
Ab Biodisk
Microbiology · 79d
Cleared Dec 23, 1998
POSITRON OPTION, MODEL NSCO-050A
K983514 · KPS
Toshiba America Medical Systems, In.C
Radiology · 77d
Cleared Dec 23, 1998
TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A
K983516 · KPS
Toshiba America Medical Systems, In.C
Radiology · 77d
Cleared Dec 23, 1998
MICRO DYNAMIC MESH
K983528 · JEY
Howmedica Corp.
Dental · 76d