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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
36289–36312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2014
PARIETENE MACROPOROUS MESH
K142091 · FTL
Sofradim Production
General & Plastic Surgery · 77d
Cleared Oct 17, 2014
T-PIECE RESUSCITATOR
K142096 · BTL
Mercury Medical
Anesthesiology · 77d
Cleared Oct 17, 2014
Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)
K142220 · CHL
Nova Biomedical Corporation
Chemistry · 66d
Cleared Oct 17, 2014
XprESS Multi-Sinus Dilation Tool
K142252 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 64d
Cleared Oct 17, 2014
Sherlock 3CG Tip Positioning System Stylet
K142267 · LJS
C.R. Bard, Inc.
General Hospital · 63d
Cleared Oct 17, 2014
Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS,...
K142589 · MAX
Titan Spine, LLC
Orthopedic · 32d
Cleared Oct 17, 2014
Merit 10mL Syringe
K142636 · FMF
Merit Medical Systems, Inc.
General Hospital · 30d
Cleared Oct 17, 2014
Antegrade LeMills Valvulotome
K142660 · MGZ
LeMaitre Vascular, Inc.
Cardiovascular · 29d
Cleared Oct 16, 2014
NDX DORSAL APPLIANCE
K133390 · LRK
Institute For Quality Resource...
Dental · 345d
Cleared Oct 16, 2014
PIEZOMED
K133488 · DZI
W&H Dentalwerk Buermoos GmbH
Dental · 337d
Cleared Oct 16, 2014
SYNGO CT SINGLE SOURCE DUAL ENERGY
K133677 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 321d
Cleared Oct 16, 2014
ELEVATION
K140023 · IOR
Pdg Product Design Group, Inc.
Physical Medicine · 283d
Cleared Oct 16, 2014
PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER
K140543 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 226d
Cleared Oct 16, 2014
PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC
K140598 · NHJ
Dima Italia Srl
Anesthesiology · 220d
Cleared Oct 16, 2014
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
K141584 · JCT
Boston Scientific Corporation
General & Plastic Surgery · 125d
Cleared Oct 16, 2014
AQUARIUS NASAL FEEDING TUBE
K141753 · PIF
Degania Silicone , Ltd.
Gastroenterology & Urology · 108d
Cleared Oct 16, 2014
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
K141801 · MCW
Covidien, LLC
Cardiovascular · 105d
Cleared Oct 16, 2014
DX-D IMAGING PACKAGE
K142184 · MQB
Agfa Healthcare N.V.
Radiology · 69d
Cleared Oct 16, 2014
Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test...
K142280 · DJG
Healgen Scientific, LLC
Chemistry · 62d
Cleared Oct 16, 2014
Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound...
K142618 · ITX
Hitachi Aloka Medical America, Inc.
Radiology · 30d
Cleared Oct 16, 2014
G-Lok and G-Lok XL Extender
K142653 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 28d
Cleared Oct 15, 2014
MULTIPULSE HOPLUS
K131987 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 474d
Cleared Oct 15, 2014
UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL
K134009 · FTC
Medtek Lighting
General & Plastic Surgery · 289d
Cleared Oct 15, 2014
AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
K140025 · LPL
Pegavision Corporation
Ophthalmic · 282d