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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68641–68664 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2004
OSSTELL MENTOR RFA
K033689 · EKX
Integration Diagnostics, Ltd.
Dental · 94d
Cleared Feb 26, 2004
DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
K040184 · DTM
Cobe Cardiovascular, Inc.
Cardiovascular · 31d
Cleared Feb 26, 2004
MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM
K040201 · JXG
Integra Neurosciences Implants S.A.
Neurology · 28d
Cleared Feb 26, 2004
CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT
K040252 · MCW
Rex Medical
Cardiovascular · 22d
Cleared Feb 25, 2004
ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM
K033053 · JCT
Alveolus, Inc.
General & Plastic Surgery · 149d
Cleared Feb 25, 2004
COLORADO MICRODISSECTION NEEDLE
K033232 · GEI
Stryker Corp.
General & Plastic Surgery · 142d
Cleared Feb 25, 2004
LIGHT AGE Q-CLEAR LASER, MODEL 701-1101
K033259 · GEX
Light Age, Inc.
General & Plastic Surgery · 139d
Cleared Feb 25, 2004
VERTEBRON PSS PEDICLE SCREW SYSTEM
K033352 · MNI
Vertebron, Inc.
Orthopedic · 128d
Cleared Feb 25, 2004
CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474,...
K033395 · GXO
Codman & Shurtleff, Inc.
Neurology · 125d
Cleared Feb 25, 2004
TRANSET FRACTURE FIXATION SYSTEM
K033717 · HTY
Bonutti Research, Inc.
Orthopedic · 91d
Cleared Feb 25, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE...
K033940 · LTT
Dade Behring, Inc.
Microbiology · 68d
Cleared Feb 25, 2004
SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975
K033981 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 64d
Cleared Feb 25, 2004
GOLDWAY UT4000A VITAL SIGNS MONITOR
K033988 · MWI
Goldway Us, Inc.
Cardiovascular · 64d
Cleared Feb 25, 2004
ELECSYS C-PEPTIDE CALCHECK
K040157 · JJX
Roche Diagnostics Corp.
Chemistry · 33d
Cleared Feb 25, 2004
BISX
K040183 · OLW
Aspect Medical Systems, Inc.
Neurology · 29d
Cleared Feb 25, 2004
MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP...
K040214 · DQA
Masimo Corp.
Anesthesiology · 26d
Cleared Feb 25, 2004
AUTOQUANT PLUS
K040326 · KPS
Adac Laboratories
Radiology · 15d
Cleared Feb 24, 2004
CREATION NM DIAGNOSTIC CATHETERS
K032888 · DQO
Neich Medical (Shenzhen) Company Limited
Cardiovascular · 161d
Cleared Feb 24, 2004
CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG...
K033030 · MWI
Witt Biomedical Corp
Cardiovascular · 151d
Cleared Feb 24, 2004
POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL...
K033564 · KGO
Kanam Latex Industries Pvt. , Ltd.
General Hospital · 104d
Cleared Feb 24, 2004
ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER
K033650 · OBJ
Siemens Medical Solutions USA, Inc.
Radiology · 96d
Cleared Feb 24, 2004
DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES
K033723 · LYZ
Baoding Guanzhong Glove Co., Ltd.
General Hospital · 90d
Cleared Feb 24, 2004
DUAL TOP ANCHOR SYSTEM SCREWS
K033767 · DZE
Jeil Medical Corporation
Dental · 83d
Cleared Feb 24, 2004
HERMES
K033996 · EBF
3M Espe AG Dental Products
Dental · 62d