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
22969–22992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 2019
Envision ultrasound pad and cover
K190802 · ITX
Civco Medical Solutions
Radiology · 56d
Cleared May 24, 2019
COMPLETE CONTROL System Gen2
K191083 · GXY
Coapt, LLC
Neurology · 30d
Cleared May 23, 2019
MaxCap Ped and MaxCap Neo
K182362 · CCK
Maxtec, LLC
Anesthesiology · 266d
Cleared May 23, 2019
IMPEDE-FX Embolization Plug
K182390 · KRD
Shape Memory Medical
Cardiovascular · 261d
Cleared May 23, 2019
Longterm NPWT Foam Dressing Kit
K182458 · OMP
Zhejiang Longterm Medical Technology...
General & Plastic Surgery · 255d
Cleared May 23, 2019
Upstream GoBack Crossing Catheter
K182937 · DQY
Upstream Peripheral Technologies, Ltd.
Cardiovascular · 213d
Cleared May 23, 2019
SYNMESH System
K183054 · MQP
Depuy Synthes Spine
Orthopedic · 202d
Cleared May 23, 2019
Luna 3D GEN2 Interbody Fusion System
K183560 · MAX
Benvenue Medical, Inc.
Orthopedic · 154d
Cleared May 23, 2019
Mariner Outrigger Revision System
K183639 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 148d
Cleared May 23, 2019
PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and...
K183654 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 147d
Cleared May 23, 2019
Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with...
K190018 · KGO
Ansell Healthcare Products, LLC
General Hospital · 139d
Cleared May 23, 2019
KATANA Zirconia Block
K190436 · EIH
Kuraray Noritake Dental, Inc.
Dental · 90d
Cleared May 23, 2019
Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert...
K190441 · QEP
Cepheid
Microbiology · 87d
Cleared May 23, 2019
Aptima BV Assay
K190452 · PQA
Hologic, Inc.
Microbiology · 87d
Cleared May 23, 2019
ERBEFLO 2 Disposable Tubing System
K190469 · OCX
Erbe USA, Inc.
Gastroenterology & Urology · 86d
Cleared May 23, 2019
Aptima Combo 2 Assay (Panther System)
K190515 · QEP
Hologic, Inc.
Microbiology · 83d
Cleared May 23, 2019
Rampart One Lumbar Interbody Fusion System
K191091 · OVD
Spineology, Inc.
Orthopedic · 29d
Cleared May 22, 2019
Dental Ceramic
K182350 · EIH
Baot Biological Technology Co., Ltd.
Dental · 266d
Cleared May 22, 2019
LIAC S
K182374 · IYE
Sit Sordina Iort Technologies Spa
Radiology · 264d
Cleared May 22, 2019
Soniquence RF Generator and Soniquence Electrodes
K183611 · GEI
Soniquence, LLC
General & Plastic Surgery · 147d
Cleared May 22, 2019
Stealth-Midas MR8 System
K183644 · OLO
Medtronic Powered Surgical Solutions
Orthopedic · 147d
Cleared May 22, 2019
cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control...
K190433 · QEP
Roche Molecular Systems, Inc.
Microbiology · 89d
Cleared May 22, 2019
HERA I10 Diagnostic Ultrasound System
K190444 · IYN
Samsung Medison Co., Ltd.
Radiology · 86d
Cleared May 22, 2019
Connector System
K190751 · NKG
Orthofix, Inc.
Orthopedic · 58d