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

Filters: Cleared only ×
175,820 results
28297–28320 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 2017
Q-Fix Suture Anchor
K172165 · MBI
ArthroCare Corporation
Orthopedic · 30d
Cleared Aug 17, 2017
BD Intima II PLUS Closed IV Catheter System
K172204 · FOZ
Becton, Dickinson and Company
General Hospital · 27d
Cleared Aug 17, 2017
Advanced Perfusion System 1
K172220 · DTQ
Terumo Cardiovascular Systems...
Cardiovascular · 24d
Cleared Aug 16, 2017
ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and...
K162768 · DSA
Integral Process Sas
Cardiovascular · 320d
Cleared Aug 16, 2017
SHOFU RESIN GLAZE
K163568 · EBD
Shofu Dental Corporation
Dental · 240d
Cleared Aug 16, 2017
GLUCOCARD W Blood Glucose Monitoring System
K170064 · NBW
Arkray Factory, Inc.
Chemistry · 219d
Cleared Aug 16, 2017
Medacta Anatomic Shoulder Prosthesis
K170910 · KWS
Medacta International S.A.
Orthopedic · 141d
Cleared Aug 16, 2017
PROPHECY INVISION Pre-operative Navigation System
K170968 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 138d
Cleared Aug 16, 2017
EXCELSIUS GPS
K171651 · OLO
Globus Medical, Inc.
Orthopedic · 72d
Cleared Aug 16, 2017
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon...
K171950 · HQD
Visionary Optics, LLC
Ophthalmic · 48d
Cleared Aug 16, 2017
ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems
K172162 · IYN
Siemens Healthcare
Radiology · 29d
Cleared Aug 16, 2017
CapSure® PS System
K172175 · NKB
Spine Wave, Inc.
Orthopedic · 28d
Cleared Aug 16, 2017
Clear Blue Digi LED Curing Light
K172426 · EBZ
Promident, LLC
Dental · 6d
Cleared Aug 15, 2017
PANA SPRAY Plus
K163483 · EFB
Nakanishi, Inc.
Dental · 246d
Cleared Aug 15, 2017
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
K163570 · DIO
Carolina Liquid Chemistries Corporation
Toxicology · 239d
Cleared Aug 15, 2017
Rapid Tox Cup II
K170222 · LAF
American Bio Medica Corp.
Toxicology · 202d
Cleared Aug 15, 2017
Aisys CS2
K170872 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 145d
Cleared Aug 15, 2017
Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
K171118 · FPA
Cair Lgl
General Hospital · 123d
Cleared Aug 15, 2017
Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face...
K171162 · FXX
Prestige Ameritech
General Hospital · 117d
Cleared Aug 15, 2017
Eclipse Treatment Planning System
K172163 · MUJ
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Aug 15, 2017
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic...
K172374 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 8d
Cleared Aug 14, 2017
ATLANTIS suprastructures
K163398 · NHA
Dentsply Sirona
Dental · 252d
Cleared Aug 14, 2017
3M Comply Hydrogen Peroxide Chemical Indicator 1248
K170321 · JOJ
3M Company
General Hospital · 194d
Cleared Aug 14, 2017
ARIX Foot System (2.3/2.8)
K170780 · HRS
Jeil Medical Corporation
Orthopedic · 152d