FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
11137–11160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 2023
Access Testosterone
K223405 · CDZ
Beckman Coulter, Inc.
Chemistry · 65d
Cleared Jan 13, 2023
Contour Knee
K223429 · MOS
Quality Electrodynamics, LLC
Radiology · 60d
Cleared Jan 13, 2023
PathLoc-TA Expandable Lumbar Cage System
K223474 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 56d
Cleared Jan 13, 2023
Medipoint Blood Lancets
K223480 · QRK
Medipoint Holdings, LLC
General & Plastic Surgery · 56d
Cleared Jan 13, 2023
MR Diffusion Perfusion Mismatch V1.0
K223502 · LLZ
Olea Medical
Radiology · 53d
Cleared Jan 13, 2023
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat...
K223746 · NCX
Zoll Circulation, Inc.
Neurology · 30d
Cleared Jan 13, 2023
Nitrile Exam Gloves (Chemotherapy Drug Tested)
K223748 · LZA
Us Medical Glove Company, LLC
General Hospital · 30d
Cleared Jan 12, 2023
Garmin ECG App
K221774 · QDA
Garmin International, Inc.
Cardiovascular · 205d
Cleared Jan 12, 2023
NeoGen PSR System
K221873 · GEI
Energist Limited
General & Plastic Surgery · 198d
Cleared Jan 12, 2023
HandX Instrument - Monopolar Spatula
K222011 · GCJ
Human Xtensions , Ltd.
General & Plastic Surgery · 189d
Cleared Jan 12, 2023
PreXion3D Expedition
K222150 · OAS
Prexion Corporation
Radiology · 176d
Cleared Jan 12, 2023
AIBOLIT 3D+
K222458 · LLZ
Aibolit Technologies, LLC
Radiology · 150d
Cleared Jan 12, 2023
Rainbow 360
K222830 · KLE
Kerr Corporation
Dental · 115d
Cleared Jan 12, 2023
MU System
K222976 · NHA
Dentis Co., Ltd.
Dental · 106d
Cleared Jan 12, 2023
MAMMOVISTA B.smart (VB70)
K223363 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared Jan 12, 2023
Neuronaute with IceCap 2 & IceCap 2 Small
K223644 · GWQ
Bioserenity
Neurology · 37d
Cleared Jan 12, 2023
NuVasive Modulus-C Interbody System
K223731 · ODP
Nuvasive, Inc.
Orthopedic · 30d
Cleared Jan 12, 2023
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD...
K223782 · EOQ
Ambu A/S
Ear, Nose, Throat · 27d
Cleared Jan 11, 2023
DD Solid Connect® CAD/CAM Abutments
K191111 · NHA
Dental Direkt GmbH
Dental · 1356d
Cleared Jan 11, 2023
Transducer Probe Cover
K221278 · ITX
Hony Medical Co., Ltd.
Radiology · 253d
Cleared Jan 11, 2023
Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl...
K222181 · LZA
Iconic Medicare Sdn Bhd
General Hospital · 173d
Cleared Jan 11, 2023
Artix BG
K223000 · QEW
Inari Medical
Cardiovascular · 105d
Cleared Jan 11, 2023
NuVasive Reline System
K223181 · NKB
Nu Vasive, Incorporated
Orthopedic · 92d
Cleared Jan 11, 2023
Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
K223295 · FDA
Fujifilm Corporaton
Gastroenterology & Urology · 77d