Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
81601–81624 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 07, 2000
R & D 3K RETIC
K003208 · JPK
R&D Systems, Inc.
Hematology · 25d
Cleared Nov 06, 2000
FRIENDLY LIGHT ER:YAG PULSED LASER
K000023 · GEX
Innotech USA, Inc.
General & Plastic Surgery · 307d
Cleared Nov 06, 2000
WILLI GELLER CREATION AND LF PORCELAIN
K002904 · EIH
Jensen Industries, Inc.
Dental · 49d
Cleared Nov 06, 2000
VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000
K002990 · HBL
Vascular Technology Incorporated
Neurology · 42d
Cleared Nov 06, 2000
PE.R.I. II KNEE FRACTURE SYSTEM
K003235 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 20d
Cleared Nov 06, 2000
MODEL K7 EVALUATION DEVICE
K003287 · KZM
Myotronics-Noromed, Inc.
Dental · 17d
Cleared Nov 06, 2000
BIOMET SCK KNEE SYSTEM
K003296 · JWH
Biomet, Inc.
Orthopedic · 17d