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
115753–115776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 1992
ALCON OPERATING MICROSCOPES
K920641 · HRM
Alcon Laboratories
General & Plastic Surgery · 240d
Cleared Oct 09, 1992
BP PUMP
K921074 · DXN
Bio-Tek Instruments, Inc.
Cardiovascular · 217d
Cleared Oct 09, 1992
SURGIFLATOR
K921264 · HIF
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 207d
Cleared Oct 09, 1992
MEDRAD PATHFINDER-E ROADMAPPING SYSTEM
K922274 · JAA
Medrad, Inc.
Radiology · 148d
Cleared Oct 09, 1992
SPECTROLYSE/PL PAI KIT
K922782 · GGP
Biopool AB
Hematology · 122d
Cleared Oct 09, 1992
CHROMOPHARE
K922836 · FSY
Berchtold Holding GmbH
General & Plastic Surgery · 119d
Cleared Oct 09, 1992
ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREW
K923256 · HWC
Alphatec Mfg., Inc.
Orthopedic · 99d
Cleared Oct 09, 1992
VISTA HPQ SYSTEM
K923615 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 80d
Cleared Oct 09, 1992
VISTA THYROXINE UPTAKE ASSAY
K923676 · KHQ
Syva Co.
Chemistry · 79d
Cleared Oct 08, 1992
BARD 7 FR. FIBER OPTIC ASSEMBLY
K923545 · FGB
C.R. Bard, Inc.
Gastroenterology & Urology · 84d
Cleared Oct 06, 1992
OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER
K913593 · CAD
Ohmeda Medical
Anesthesiology · 420d
Cleared Oct 06, 1992
HALO ESPRIT
K920117 · JEC
Itm Corp.
Orthopedic · 267d
Cleared Oct 06, 1992
OVER THE NEEDLE SPLITABLE CATHETER W/FUNNEL LOCATO
K920907 · DYB
Teleflexmedical, Inc.
Cardiovascular · 222d
Cleared Oct 06, 1992
OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1
K920908 · DYB
Teleflexmedical, Inc.
Cardiovascular · 222d
Cleared Oct 06, 1992
RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED
K921002 · BTM
Rondex Products, Inc.
Anesthesiology · 224d
Cleared Oct 06, 1992
DISPOSABLE PROTECTIVE SHEATH
K921244 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 204d
Cleared Oct 06, 1992
MODEL PC ARGON ION LASER
K921300 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 202d
Cleared Oct 06, 1992
K-DISPERSE
K921679 · GZJ
Katecho, Inc.
Neurology · 181d
Cleared Oct 06, 1992
REMUSK MP
K922029 · LBB
Equipement Biomedical Specialise, Inc.
Neurology · 158d
Cleared Oct 06, 1992
MODELS M1175A AND M1176A COMPONENT MONITORING SYST
K922058 · MHX
Hewlett-Packard Co.
Cardiovascular · 167d
Cleared Oct 06, 1992
STERILE SURGEONS GLOVES -- MODIFICATION
K922769 · KGO
Real Latex Pvt. , Ltd.
General Hospital · 143d
Cleared Oct 06, 1992
COMBINE II WETPROOF PAD
K923116 · NAB
Hermitage Hospital Products, Inc.
General & Plastic Surgery · 103d
Cleared Oct 06, 1992
INSTRUMENTARIUM MEGA4 HT
K923352 · LNH
Instrumentarium Imaging, Inc.
Radiology · 90d
Cleared Oct 06, 1992
PHARYNGEAL SALIVARY BYPASS TUBE
K923355 · KCF
Boston Medical Products, Inc.
Ear, Nose, Throat · 90d