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
79345–79368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 2001
HINT AUDIOMETER, OR HINT
K003913 · EWO
Maico-Diagnostics
Ear, Nose, Throat · 87d
Cleared Mar 16, 2001
INDIGO LASEROPTIC TREATMENT SYSTEM
K003952 · GEX
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 85d
Cleared Mar 16, 2001
INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001
K003953 · GEX
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 85d
Cleared Mar 16, 2001
MRI SAFE INSTRUMENTS
K003965 · GEA
Aesculap, Inc.
General & Plastic Surgery · 84d
Cleared Mar 16, 2001
SPECULITE/ORALLITE
K003995 · EAZ
Trylon Corp.
Dental · 80d
Cleared Mar 16, 2001
MD 30 COMPACT
K004014 · GEX
General Project
General & Plastic Surgery · 84d
Cleared Mar 16, 2001
REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP
K010084 · GWQ
Excel Tech. , Ltd.
Neurology · 64d
Cleared Mar 16, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
K010206 · KHS
Dade Behring, Inc.
Chemistry · 52d
Cleared Mar 16, 2001
VISTAKON (HEFILCON C) CONTACT LENSES
K010218 · LPL
Vistakon
Ophthalmic · 51d
Cleared Mar 16, 2001
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...
K010223 · LPL
American Contact Lens, Inc.
Ophthalmic · 51d
Cleared Mar 16, 2001
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000
K010266 · NBC
Biosite Incorporated
Chemistry · 46d
Cleared Mar 16, 2001
SCIMEDX PHASE II PR3 IGG ANTIBODY EIA
K010287 · MOB
Scimedx Corp.
Immunology · 44d
Cleared Mar 16, 2001
MN-4 COARSE MANIPULATOR
K010298 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 44d
Cleared Mar 16, 2001
CBC-SF
K010409 · JPK
R&D Systems, Inc.
Hematology · 32d
Cleared Mar 16, 2001
PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
K010445 · FGE
Cordis Corp.
Gastroenterology & Urology · 30d
Cleared Mar 16, 2001
SAFARI
K010606 · INI
Ranger All Season Corp.
Physical Medicine · 15d
Cleared Mar 16, 2001
ACCUSONIC, MODEL AS-260
K010609 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 15d
Cleared Mar 15, 2001
YORAMED, MODEL T-202
K002297 · GZJ
United Yoram Distributors, Inc.
Neurology · 230d
Cleared Mar 15, 2001
WISEBANDS SKIN CLOSURE DEVICE
K002315 · MKY
Wisebands , Ltd.
General & Plastic Surgery · 227d
Cleared Mar 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
K003267 · DAP
Sigma Diagnostics, Inc.
Hematology · 148d
Cleared Mar 15, 2001
DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
K003301 · JOY
CellaVision AB
Hematology · 146d
Cleared Mar 15, 2001
MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2
K003344 · CAF
Medical Depot, Inc.
Anesthesiology · 141d
Cleared Mar 15, 2001
RANDOX GLUCOSE (GOD/PAP)
K003346 · CGA
Randox Laboratories, Ltd.
Chemistry · 141d
Cleared Mar 15, 2001
N PROTEIN STANDARD UY CALIBRATOR
K003501 · JIT
Dade Behring, Inc.
Chemistry · 122d