FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
29449–29472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 2017
POGO Automatic Blood Glucose Monitoring System
K162203 · NBW
Intuity Medical, Inc.
Chemistry · 244d
Cleared Apr 06, 2017
Synapse 3D Perfusion Analysis
K162287 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 234d
Cleared Apr 06, 2017
Optiflux dialyzer
K162488 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 211d
Cleared Apr 06, 2017
NobleStitch EL
K162617 · GAW
Nobles Medical Technologies Ii, Inc.
General & Plastic Surgery · 198d
Cleared Apr 06, 2017
AcQGuide Steerable Sheath
K162925 · DRA
Acutus Medical, Inc.
Cardiovascular · 169d
Cleared Apr 06, 2017
PRECICE UNYTE CoCr System
K162927 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 169d
Cleared Apr 06, 2017
CEDIA Buprenorphine II Assay
K163101 · DJG
Microgenics Corporation
Toxicology · 150d
Cleared Apr 06, 2017
Atellica CH Phencyclidine (Pcp)
K163220 · LCM
Siemens Healthcare Diagnostics, Inc.
Toxicology · 141d
Cleared Apr 06, 2017
MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension...
K163233 · DQY
Mivi Neuroscience, Inc.
Cardiovascular · 140d
Cleared Apr 06, 2017
Leva Anterior Expandable Spacer System
K163246 · MAX
Spine Wave, Inc.
Orthopedic · 139d
Cleared Apr 06, 2017
Dual Mode Infrared Thermometer
K163256 · FLL
Intelliworks, LLC
General Hospital · 136d
Cleared Apr 06, 2017
ViziShot 2 FLEX
K163469 · KTI
Olympus Surgical Technologies America
Ear, Nose, Throat · 115d
Cleared Apr 06, 2017
Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad,...
K170088 · OMP
Medela AG
General & Plastic Surgery · 86d
Cleared Apr 06, 2017
IOLMaster 700
K170171 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 77d
Cleared Apr 06, 2017
CORE M2 Vascular System
K170385 · IYO
Volcano Corporation
Radiology · 57d
Cleared Apr 06, 2017
Inqwire Diagnostic Guide Wire
K170700 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Apr 05, 2017
NILE Proximal Fixation Spinal System
K161332 · OWI
K2m, Inc.
Orthopedic · 328d
Cleared Apr 05, 2017
LIFESYS PACS
K161341 · LLZ
Lifetrack Medical Systems, Inc.
Radiology · 327d
Cleared Apr 05, 2017
Arm automatic blood pressure monitor
K161712 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 288d
Cleared Apr 05, 2017
UltraScan 650
K161919 · MUA
Cyberlogic, Inc.
Radiology · 266d
Cleared Apr 05, 2017
C-Reactive Protein Kit for use on SPAPLUS
K161982 · DCN
The Binding Site Group
Immunology · 260d
Cleared Apr 05, 2017
ExactechGPS Total Shoulder Application, Equinoxe Planning Software
K162567 · OLO
Blue Ortho
Orthopedic · 203d
Cleared Apr 05, 2017
Segment CMR
K163076 · LLZ
Medviso AB
Radiology · 153d
Cleared Apr 05, 2017
AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
K163274 · JOZ
Aggredyne, Inc.
Hematology · 135d