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
65617–65640 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2005
COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE (PINK, BLUE,...
K051345 · LYY
Glovco (M) Sdn. Bhd.
General Hospital · 31d
Cleared Jun 23, 2005
3.0T PROSTATE IMAGING SYSTEM
K051349 · MOS
Medrad, Inc.
Radiology · 30d
Cleared Jun 23, 2005
RESTORATION MODULAR SYSTEM
K051363 · JDI
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Jun 23, 2005
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM
K051374 · DQX
Stereotaxis, Inc.
Cardiovascular · 28d
Cleared Jun 23, 2005
ENDOTINE RIBBON
K051415 · GAM
Coapt Systems, Inc.
General & Plastic Surgery · 22d
Cleared Jun 22, 2005
ZODIAC SPINAL FIXATION SYSTEM
K050830 · KWP
Alphatec/Nexmed
Orthopedic · 82d
Cleared Jun 22, 2005
CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM
K050852 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 79d
Cleared Jun 22, 2005
PERIPHERAL CUTTING BALLOON
K051254 · PNO
Boston Scientific Ivt
Cardiovascular · 37d
Cleared Jun 22, 2005
MD TURBO
K051284 · CAF
Respirics, Inc.
Anesthesiology · 40d
Cleared Jun 22, 2005
NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR
K051425 · HCG
Micro Therapeutics, Inc.
Neurology · 21d
Cleared Jun 22, 2005
INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
K051499 · FPA
Medegen Medical Manufacturing Services
General Hospital · 15d
Cleared Jun 21, 2005
MODEL 2500A PALMSAT PULSE OXIMETER
K050056 · DQA
Nonin Medical, Inc.
Anesthesiology · 161d
Cleared Jun 21, 2005
MODEL 250 SERIES MATERNAL/FETAL MONITOR
K050583 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 106d
Cleared Jun 21, 2005
GE DATEX-OHMEDA CENTIVA/5 VENTILATOR
K050860 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 77d
Cleared Jun 21, 2005
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K051148 · LYZ
Zibo Sinocare Plastic Products Co., Ltd.
General Hospital · 48d
Cleared Jun 21, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/ML
K051183 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Jun 21, 2005
CAVEX ORTHOTRACE
K051207 · ELW
Cavex Holland BV
Dental · 41d
Cleared Jun 21, 2005
OMRON MODEL 514N TYMPANIC THERMOMETER
K051233 · FLL
Omron Healthcare, Inc.
General Hospital · 39d
Cleared Jun 21, 2005
ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS
K051335 · JDI
Exactech, Inc.
Orthopedic · 29d
Cleared Jun 21, 2005
KODAK DIRECTVIEW DR SYSTEM DETECTOR
K051483 · MQB
Eastman Kodak Company
Radiology · 15d
Cleared Jun 21, 2005
SPI DENTAL IMPLANT
K051502 · DZE
Thommen Medical AG
Dental · 14d
Cleared Jun 21, 2005
FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)
K051519 · LIT
Abbott Laboratories (Perclose, Inc.)
Cardiovascular · 13d
Cleared Jun 20, 2005
MANZI CLEANER SYSTEM
K043314 · NVE
Langford IC Systems, Inc.
General Hospital · 201d
Cleared Jun 20, 2005
30 ML OR 60 ML PEDI-SYRINGE FILTER
K050805 · BRZ
Blood Products Specialties, LLC
General Hospital · 82d