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
27649–27672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 2017
Matrixx System
K171140 · ODP
Nexxt Spine, LLC
Orthopedic · 126d
Cleared Aug 22, 2017
VERIFY Assert VH2O2 Self-Contained Biological Indicator
K171504 · FRC
STERIS Corporation
General Hospital · 91d
Cleared Aug 22, 2017
Monopolar Single Use Laparoscopic Instrument
K171523 · GEI
Getsch+Hiller Medizintechnik GmbH
General & Plastic Surgery · 89d
Cleared Aug 22, 2017
VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator
K171587 · FRC
STERIS Corporation
General Hospital · 83d
Cleared Aug 22, 2017
OKI Surgical Planning Software
K171617 · LLZ
Ortho Kinematics, Inc.
Radiology · 82d
Cleared Aug 22, 2017
Grivamax Hair Growth System
K171895 · OAP
Leana Orders, Inc.
General & Plastic Surgery · 57d
Cleared Aug 22, 2017
EzDent-i / E2 / Prora View
K172364 · LLZ
Ewoosoft Co., Ltd.
Radiology · 18d
Cleared Aug 22, 2017
Stryker Integrated Bipolar Cord and Tubing Sets
K172367 · GEI
Stryker Instruments
General & Plastic Surgery · 18d
Cleared Aug 21, 2017
INFINITY™ OCT System
K163375 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 263d
Cleared Aug 21, 2017
ShockPulse-SE Lithotripsy System
K171024 · FEO
Cybersonics, Inc.
Gastroenterology & Urology · 138d
Cleared Aug 21, 2017
Sorbact Wound Dressing-Ribbon Gauze
K171225 · FRO
Abigo Medical AB
General & Plastic Surgery · 117d
Cleared Aug 21, 2017
Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with...
K171276 · KGO
Tg Medical Sdn. Bhd.
General Hospital · 112d
Cleared Aug 21, 2017
MAMBA and MAMBA FLEX Microcatheters
K171452 · DQY
Boston Scientific Corporation
Cardiovascular · 96d
Cleared Aug 21, 2017
Ceribell Instant EEG Headband
K171459 · GXY
Ceribell, Inc.
Neurology · 95d
Cleared Aug 21, 2017
RIDA GENE Norovirus GI/GII
K171511 · PIQ
R-Biopharm AG
Microbiology · 89d
Cleared Aug 21, 2017
Zenius™, lliad™ and Kora™ Spinal Fixation Systems
K171526 · NKB
Medyssey USA, Inc.
Orthopedic · 88d
Cleared Aug 21, 2017
Approach CTO Microwire Guide
K171897 · DQX
Cook Incorporated
Cardiovascular · 56d
Cleared Aug 21, 2017
Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation...
K172107 · NKB
Spineology, Inc.
Orthopedic · 40d
Cleared Aug 18, 2017
s LDL-EX SEIKEN
K161679 · PYP
Denka Seiken Co., Ltd.
Chemistry · 427d
Cleared Aug 18, 2017
ARK Methotrexate Assay
K163359 · LAO
ARK Diagnostics, Inc.
Toxicology · 261d
Cleared Aug 18, 2017
Diazyme DZ-Lite Total beta-hCG Test System
K163418 · DHA
Diazyme Laboratories
Chemistry · 255d
Cleared Aug 18, 2017
Zip 4 Skin Closure Device
K170003 · PYO
Zipline Medical, Inc.
General & Plastic Surgery · 227d
Cleared Aug 18, 2017
3DMetal Tibial Cones
K170149 · JWH
Medacta International S.A.
Orthopedic · 213d
Cleared Aug 18, 2017
CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill...
K170431 · DXT
Coeur, Inc.
Cardiovascular · 186d