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
70753–70776 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 2003
EDWARDS PERIPHERAL DILATATION CATHETER
K032587 · DQY
Edwards Lifesciences, LLC
Cardiovascular · 41d
Cleared Oct 02, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
K032616 · LYZ
Elite International, Inc.
General Hospital · 38d
Cleared Oct 02, 2003
IMMIX PLASTIFILM
K032673 · FTL
Osteobiologics, Inc.
General & Plastic Surgery · 34d
Cleared Oct 02, 2003
HL888BF
K032695 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Oct 02, 2003
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K032712 · MSD
Boston Scientific Corp
Gastroenterology & Urology · 30d
Cleared Oct 02, 2003
CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA...
K032737 · DQY
Cordis Europa, N.V.
Cardiovascular · 28d
Cleared Oct 02, 2003
MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE
K032750 · DZE
Friandent GmbH
Dental · 27d
Cleared Oct 02, 2003
MICROMLC
K032790 · IXI
Siemens Medical Solutions USA, Inc.
Radiology · 24d
Cleared Oct 02, 2003
OPTICAL SEPARATOR
K032889 · GCJ
Applied Medical Resources
General & Plastic Surgery · 15d
Cleared Oct 02, 2003
HL888 AF
K032913 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Oct 01, 2003
CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061,...
K022505 · EGS
NOUVAG AG
Dental · 429d
Cleared Oct 01, 2003
ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER
K024023 · NFB
Essex Medical Systems Plus
Anesthesiology · 300d
Cleared Oct 01, 2003
CLS-2000 UNIT
K024133 · FLE
Dentsply Intl.
General Hospital · 289d
Cleared Oct 01, 2003
CYNOSURE SMART 2940D ER:YAG LASER
K031389 · GEX
Cynosure, Inc.
General & Plastic Surgery · 152d
Cleared Oct 01, 2003
SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER
K031440 · GEX
Cynosure, Inc.
General & Plastic Surgery · 148d
Cleared Oct 01, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K031523 · LFL
Aomori Olympus Co., Ltd.
General & Plastic Surgery · 139d
Cleared Oct 01, 2003
CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W
K031922 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 100d
Cleared Oct 01, 2003
W.O.M. LASER U100PLUS
K032023 · GEX
W.O.M. World of Medicine AG
General & Plastic Surgery · 93d
Cleared Oct 01, 2003
LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE
K032072 · HWC
Arthrotek, Inc.
Orthopedic · 90d
Cleared Oct 01, 2003
PERIFIX CATHETER CONNECTOR
K032144 · CAZ
B.Braun Medical, Inc.
Anesthesiology · 79d
Cleared Oct 01, 2003
APPOLLO 3 ALLOY
K032320 · EJT
Dentsply International
Dental · 65d
Cleared Oct 01, 2003
DISTAL RADIUS FRACTURE REPAIR SYSTEM
K032705 · LXT
Hand Innovations, Inc.
Orthopedic · 29d
Cleared Oct 01, 2003
TRIGEN STRAIGHT HUMERAL NAIL SYSTEM
K032722 · HSB
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Oct 01, 2003
BIOSIGN STEAM-24 BIOLOGICAL INDICATOR
K032723 · FRC
Getinge USA, Inc.
General Hospital · 28d