FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76561–76584 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 2002
HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE
K014073 · FMF
Portex, Inc.
General Hospital · 65d
Cleared Feb 13, 2002
ENDIUS CERVICAL PLATE SYSTEM
K014107 · KWQ
Endius, Inc.
Orthopedic · 62d
Cleared Feb 13, 2002
AOS CANNULATED BONE SCREW SYSTEM
K014185 · HWC
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 55d
Cleared Feb 13, 2002
DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH...
K014288 · KGO
Wrp Specialty Products Sdn. Bhd.
General Hospital · 47d
Cleared Feb 13, 2002
OMNIA X/XS ULTRASOUND SYSTEM
K020353 · IYN
Siemens Medical Systems, Inc.
Radiology · 9d
Cleared Feb 13, 2002
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K994055 · FRC
Advanced Sterilization Products
General Hospital · 806d
Cleared Feb 12, 2002
BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T
K010452 · DPW
Koven Technology, Inc.
Cardiovascular · 362d
Cleared Feb 12, 2002
COBE REVOLUTION
K011835 · KFM
Cobe Cardiovascular, Inc.
Cardiovascular · 245d
Cleared Feb 12, 2002
SENSAID
K011974 · DQA
Sensidyne, Inc.
Anesthesiology · 232d
Cleared Feb 12, 2002
DRG REACTION CHAMBER/SAFETY TIP
K012003 · HEI
Doctor'S Research Group, Inc.
Obstetrics & Gynecology · 230d
Cleared Feb 12, 2002
AEROPEP
K012368 · BWF
Trudell Medical Intl.
Anesthesiology · 201d
Cleared Feb 12, 2002
ORION DIGITAL IMAGING SYSTEM
K012490 · OWB
Infimed, Inc.
Radiology · 193d
Cleared Feb 12, 2002
REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
K012675 · JOW
Adven Medical
Cardiovascular · 182d
Cleared Feb 12, 2002
TWIN PLUS
K012976 · OLV
Grass-Telefactor Divison
Neurology · 160d
Cleared Feb 12, 2002
RUSCH MEMORY BAG
K013872 · GCJ
Rusch Intl.
General & Plastic Surgery · 83d
Cleared Feb 12, 2002
BACFIX SPINAL FIXATION SYSTEM
K013887 · MNH
Spinal Concepts, Inc.
Orthopedic · 81d
Cleared Feb 12, 2002
BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230
K013904 · GEI
Baylis Medical Co., Inc.
General & Plastic Surgery · 78d
Cleared Feb 12, 2002
WATERLASE MILLENNIUM
K013908 · MXF
Biolase Technology, Inc.
Dental · 78d
Cleared Feb 12, 2002
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0
K014261 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 47d
Cleared Feb 12, 2002
TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
K020083 · HRX
Tuta Healthcare Pty Limited
Orthopedic · 33d
Cleared Feb 12, 2002
E-SCAN XQ
K020164 · LNH
Biosound Esaote, Inc.
Radiology · 26d
Cleared Feb 12, 2002
HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
K020232 · CGA
Hypoguard USA, Inc.
Chemistry · 29d
Cleared Feb 12, 2002
NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA
K020295 · JWH
Implex Corp.
Orthopedic · 15d
Cleared Feb 12, 2002
MODIFICATION TO VISTA STEREOSCOPE SYSTEM
K020301 · FET
Vista Medical Technologies, Inc.
Gastroenterology & Urology · 14d