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
71785–71808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 2003
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES
K023454 · CCK
Datex-Ohmeda
Anesthesiology · 190d
Cleared Apr 23, 2003
RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000
K024342 · IXW
Daito Co., Ltd.
Radiology · 117d
Cleared Apr 23, 2003
F1 DIODE LASER SYSTEM
K030235 · GEX
Opus Medical, Inc.
General & Plastic Surgery · 90d
Cleared Apr 23, 2003
ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314
K030243 · DZE
Imtec Corp.
Dental · 90d
Cleared Apr 23, 2003
AXCEL SURGICAL LIGHT
K030906 · FSY
Alm
General & Plastic Surgery · 30d
Cleared Apr 23, 2003
STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090,...
K030937 · CAZ
Arrow International, Inc.
Anesthesiology · 29d
Cleared Apr 23, 2003
VTI 20 MHZ GATED DOPPLER
K031091 · DPW
Vascular Technology Incorporated
Cardiovascular · 16d
Cleared Apr 22, 2003
VITALCARE URETHRAL CATHETER
K021938 · GBM
Vitalcare, Inc.
Gastroenterology & Urology · 314d
Cleared Apr 22, 2003
VITALCARE FOLEY CATHETER
K021939 · EZL
Vitalcare, Inc.
Gastroenterology & Urology · 314d
Cleared Apr 22, 2003
MASTERGRAFT MATRIX
K023553 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 181d
Cleared Apr 22, 2003
NOVAVISION, MODEL 2.0
K023623 · HPT
Novavision, Inc.
Neurology · 175d
Cleared Apr 22, 2003
INSORB ABSORBABLE STAPLES, MODEL SP-B20
K024117 · GDW
Incisive Surgical, Inc.
General & Plastic Surgery · 130d
Cleared Apr 22, 2003
WORRY-REMOVER IRRIGATOR
K030056 · HED
Corisen Group, Ltd.
Obstetrics & Gynecology · 106d
Cleared Apr 22, 2003
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
K030129 · DQK
Endocardial Solutions, Inc.
Cardiovascular · 98d
Cleared Apr 22, 2003
BABY POD
K030283 · FPP
Prism Enterprises, Inc.
General Hospital · 85d
Cleared Apr 22, 2003
SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM
K030310 · HRS
Synthes (Usa)
Orthopedic · 82d
Cleared Apr 22, 2003
STEELEX ELECTRODE SET
K030556 · LDF
Aesculap, Inc.
Cardiovascular · 60d
Cleared Apr 22, 2003
MODIFICATION TO HIOX
K030943 · CBP
Sensor Medics Corp.
Anesthesiology · 27d
Cleared Apr 21, 2003
NICOLET PIONEER TC8080
K020754 · IYN
Nicolet Biomedical
Radiology · 410d
Cleared Apr 21, 2003
LONG WELL LW-6DXX SERIES BODY FAT ANALYZER
K030203 · MNW
Long Well Electronics Corp.
Gastroenterology & Urology · 90d
Cleared Apr 21, 2003
T-SCIENTIFIC T-PAD
K030334 · QSY
T-Scientific, Inc.
General & Plastic Surgery · 80d
Cleared Apr 21, 2003
COULTER LH 750 BODY FLUIDS APPLICATION
K030606 · GKZ
Beckman Coulter, Inc.
Hematology · 55d
Cleared Apr 21, 2003
IBD-QUIK CHEK
K030704 · DEG
Techlab, Inc.
Immunology · 46d
Cleared Apr 21, 2003
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K030782 · FTM
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 41d