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
80473–80496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 2000
STELLAR
K002463 · FSY
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 90d
Cleared Nov 08, 2000
WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
K002473 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 89d
Cleared Nov 08, 2000
BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH...
K002499 · BZG
Brentwood Medical Technology Corp.
Anesthesiology · 86d
Cleared Nov 08, 2000
CERAM-PRIME
K002502 · KLE
S & C Polymer GmbH
Dental · 86d
Cleared Nov 08, 2000
FREEDOM AUTOMATIC FILM PROCESSOR
K002640 · IXW
J. Morita USA, Inc.
Radiology · 76d
Cleared Nov 08, 2000
PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING
K002707 · DQX
Precision Vascular Systems, Inc.
Cardiovascular · 70d
Cleared Nov 08, 2000
CARESIDE CHOLINESTERASE
K002792 · DIH
Careside, Inc.
Chemistry · 62d
Cleared Nov 08, 2000
IRIS RETRACTING PHACOEMULSIFICATION SLEEVE
K002812 · HQC
Michael Reynard, M.D.
Ophthalmic · 61d
Cleared Nov 08, 2000
OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B)...
K002966 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 47d
Cleared Nov 08, 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS...
K003167 · DQA
Masimo Corp.
Anesthesiology · 29d
Cleared Nov 08, 2000
PERSONAL ECG TRANSMITTER, MODEL CG-6550
K003220 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 23d
Cleared Nov 08, 2000
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP...
K003244 · DQA
Masimo Corp.
Anesthesiology · 22d
Cleared Nov 08, 2000
PCCR DIGITAL IMAGING DEVICE
K003256 · MQB
Orex Computed Radiography, Ltd.
Radiology · 22d
Cleared Nov 08, 2000
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER...
K003315 · JOH
Mallinckrodt, Inc.
Anesthesiology · 16d
Cleared Nov 08, 2000
QWH-149 WRIST ARRAY COIL
K003331 · MOS
Mri Devices Corp.
Radiology · 15d
Cleared Nov 08, 2000
OBC-149 BREAST ARRAY COIL
K003340 · MOS
Mri Devices Corp.
Radiology · 14d
Cleared Nov 07, 2000
KM-10 TENS ELECTRODE
K000870 · GXY
Katecho, Inc.
Neurology · 232d
Cleared Nov 07, 2000
CNS-9300 SERIES CENTRAL STATION
K001433 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 183d
Cleared Nov 07, 2000
ETHIBOND EXCEL VALVE LOOP SUTURE
K003070 · DXZ
Ethicon, Inc.
Cardiovascular · 36d
Cleared Nov 07, 2000
MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
K003087 · MED
Sporicidin Intl.
General Hospital · 41d
Cleared Nov 07, 2000
MULTIPLE-VINYL EXAM GLOVE, POWDERED
K003133 · LYZ
Excellence Ent. Co., Ltd.
General Hospital · 32d
Cleared Nov 07, 2000
IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ
K003181 · LPH
Implex Corp.
Orthopedic · 27d
Cleared Nov 07, 2000
DUPLOGRIP
K003193 · FMF
Baxter Healthcare Corp
General Hospital · 26d
Cleared Nov 07, 2000
BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT
K003204 · GNW
Intracel Corp.
Microbiology · 25d