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
22825–22848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 2019
Eon FR
K180511 · PKT
Dominion Aesthetic Technologies, Inc.
General & Plastic Surgery · 470d
Cleared Jun 12, 2019
Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double...
K182749 · HGX
Lansinoh Laboratories Saglik...
Obstetrics & Gynecology · 257d
Cleared Jun 12, 2019
Aquilion ONE (TSX-305A/6) V8.9 with AiCE
K183046 · JAK
Canon Medical Systems Corporation
Radiology · 222d
Cleared Jun 12, 2019
Medline Poly-Cath Red Polymer Urethral Catheter
K183335 · GBM
Medline Industries, Inc.
Gastroenterology & Urology · 191d
Cleared Jun 12, 2019
PENTAX Medical ENT Video Imaging System
K183691 · EOB
Pentax of America, Inc.
Ear, Nose, Throat · 163d
Cleared Jun 12, 2019
Avid IF2
K183692 · LIH
Vision Quest Industries Inc./Dba VQ...
Neurology · 163d
Cleared Jun 12, 2019
Lateral Plate System
K190016 · KWQ
Corelink, LLC
Orthopedic · 160d
Cleared Jun 12, 2019
J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow...
K190177 · KNW
Ranfac Corporation
General & Plastic Surgery · 131d
Cleared Jun 12, 2019
Phasix ST Mesh with Open Positioning System
K190185 · OWT
C.R. Bard, Inc.
General & Plastic Surgery · 131d
Cleared Jun 12, 2019
Viveve System 2.0
K190422 · GEI
Viveve Medical
General & Plastic Surgery · 111d
Cleared Jun 12, 2019
Aequalis Ascend Flex Shoulder System
K190521 · KWS
Tornier S.A.S.
Orthopedic · 100d
Cleared Jun 12, 2019
On Call Express Voice Blood Glucose Monitoring System
K191038 · NBW
ACON Laboratories, Inc.
Chemistry · 55d
Cleared Jun 12, 2019
HS40 Diagnostic Ultrasound System
K191055 · IYN
Samsung Medison Co., Ltd.
Radiology · 54d
Cleared Jun 12, 2019
Argon Handset
K191064 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 51d
Cleared Jun 12, 2019
RS85 Diagnostic Ultrasound System
K191115 · IYN
Samsung Medison Co., Ltd.
Radiology · 47d
Cleared Jun 12, 2019
Wallace Dual Lumen Oocyte Recovery System
K191291 · MQE
CooperSurgical, Inc.
Obstetrics & Gynecology · 29d
Cleared Jun 12, 2019
Life Sensor Cardiac Monitor
K191331 · DRG
Braveheart Wireless, Inc.
Cardiovascular · 27d
Cleared Jun 11, 2019
NOVA Minimally Invasive System
K182416 · NKB
Baui Biotech Co., Ltd.
Orthopedic · 280d
Cleared Jun 11, 2019
JAMBRO Single Core A Sterilization wrap
K182656 · FRG
Jiangsu Zhande Medical Supplies Co.,...
General Hospital · 259d
Cleared Jun 11, 2019
Scoreflex PTA Scoring Balloon Catheter
K182713 · PNO
Orbusneich Medical Trading, Inc.
Cardiovascular · 257d
Cleared Jun 11, 2019
Arthrex SwiveLock Suture Anchor
K191226 · MAI
Arthrex, Inc.
Orthopedic · 35d
Cleared Jun 11, 2019
Force Fiber Suture
K191268 · GAT
Teleflex Medical Incorporated
General & Plastic Surgery · 29d
Cleared Jun 11, 2019
T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System,...
K191271 · HSB
Stryker Trauma GmbH
Orthopedic · 29d
Cleared Jun 11, 2019
Spine & Trauma Navigation
K191285 · OLO
Brainlab AG
Orthopedic · 29d