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
33337–33360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 2015
U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood...
K151100 · NBW
Taidoc Technology Corporation
Chemistry · 158d
Cleared Sep 29, 2015
Neon EEG
K151576 · GXY
Incereb, Ltd.
Neurology · 110d
Cleared Sep 29, 2015
MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM...
K151579 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 110d
Cleared Sep 29, 2015
SureSigns VS3, SureSigns VS4
K151761 · DSJ
Phillips Medical Systems
Cardiovascular · 92d
Cleared Sep 29, 2015
Intradermal Adapter
K151777 · FMF
West Pharmaceutical Services, Inc.
General Hospital · 90d
Cleared Sep 29, 2015
LOGIQ S8
K152195 · IYN
Ge Healthcare
Radiology · 55d
Cleared Sep 29, 2015
Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series
K152483 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 29d
Cleared Sep 28, 2015
ARIX Ankle System
K152158 · KTT
Jeil Medical Corporation
Orthopedic · 56d
Cleared Sep 28, 2015
Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4
K152171 · KTT
Orthofix Srl
Orthopedic · 55d
Cleared Sep 28, 2015
Onrad Treatment System
K152488 · MUJ
Accuray Incorporated
Radiology · 28d
Cleared Sep 25, 2015
Bluefin Interbody System
K143479 · MAX
Tides Medical
Orthopedic · 291d
Cleared Sep 25, 2015
Endoluminal Occlusion System-EOS
K150402 · KRD
Artventive Medical Group, Inc.
Cardiovascular · 219d
Cleared Sep 25, 2015
U2 Total Knee System- Additional Sizes
K150829 · JWH
United Orthopedic Corporation
Orthopedic · 179d
Cleared Sep 25, 2015
U2 Femoral Component, CR, Porous Coated, Additional Sizes
K150832 · MBH
United Orthopedic Corporation
Orthopedic · 179d
Cleared Sep 25, 2015
DePuy Actis Duofox Hip Prosthesis
K150862 · MEH
DePuy Orthopaedics, Inc.
Orthopedic · 177d
Cleared Sep 25, 2015
AZUR CX Detachable 35 Coils
K151358 · KRD
MicroVention, Inc.
Cardiovascular · 128d
Cleared Sep 25, 2015
NuVasive X-CORE Mini Cervical Expandable VBR System
K151651 · PLR
Nu Vasive, Incorporated
Orthopedic · 99d
Cleared Sep 25, 2015
Alere Afinion HbA1c, Alere Afinion AS100 Analyzer
K151809 · LCP
Alere Technologies AS
Chemistry · 85d
Cleared Sep 25, 2015
X-spine Pedicle Screw System
K152132 · MNI
X-Spine Systems, Inc.
Orthopedic · 56d
Cleared Sep 25, 2015
Renovis Anterior Cervical Plate System
K152193 · KWQ
Renovis Surgical Technologies, Inc.
Orthopedic · 51d
Cleared Sep 25, 2015
BiowaveHOME Neuromodulation Pain Therapy Device
K152437 · GZJ
Biowave Corporation
Neurology · 29d
Cleared Sep 24, 2015
neon3
K150650 · NKG
Ulrich GmbH & Co. KG
Orthopedic · 196d
Cleared Sep 24, 2015
U & U Intravascular Administration Set
K151151 · FPA
U&U Medical Technology Co, Ltd.
General Hospital · 147d
Cleared Sep 24, 2015
Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
K151293 · KWS
Tornier S.A.S.
Orthopedic · 132d