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
9121–9144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 2023
Spinery™ RF Ablation System
K223303 · GEI
Axon Spine Medical System
Orthopedic · 307d
Cleared Aug 30, 2023
Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non...
K223130 · BTR
Covidien
Anesthesiology · 331d
Cleared Aug 30, 2023
MONTAGE Settable, Resorbable Hemostatic Bone Putty
K213418 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 679d
Cleared Aug 29, 2023
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420)
K232313 · FZP
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 27d
Cleared Aug 29, 2023
ARROW Off-Centred Humeral Insert
K232226 · PHX
FH Industrie
Orthopedic · 33d
Cleared Aug 29, 2023
StarFin
K231407 · HIF
Premium Medical Technology, LLC
Obstetrics & Gynecology · 106d
Cleared Aug 29, 2023
Precice Ankle Salvage System
K230765 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 162d
Cleared Aug 29, 2023
circul™ pro Ring
K221361 · DQA
Bodimetrics, LLC
Anesthesiology · 475d
Cleared Aug 28, 2023
Treace Medical Concepts (TMC) Compression Implant System
K232387 · JDR
Treace Medical Concepts
Orthopedic · 19d
Cleared Aug 28, 2023
CALLISTO eye
K231676 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 80d
Cleared Aug 28, 2023
Distal Elbow Plating System
K231623 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 87d
Cleared Aug 28, 2023
SofWave System
K231537 · OHV
Sofwave Medical, Ltd.
General & Plastic Surgery · 90d
Cleared Aug 28, 2023
KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with...
K231435 · LZA
Kimberly Clark Corporation
General Hospital · 103d
Cleared Aug 28, 2023
Precision GI
K231422 · FCG
Limaca Medical, Ltd.
Gastroenterology & Urology · 103d
Cleared Aug 28, 2023
QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular...
K230221 · IYX
Versant Medical Physics and Radiation...
Radiology · 214d
Cleared Aug 28, 2023
SoundBite® Crossing System XS Peripheral
K230159 · PDU
Soundbite Medical Solutions, Inc.
Cardiovascular · 221d
Cleared Aug 28, 2023
VisAble.IO
K223639 · QTZ
Techsomed
Radiology · 266d
Cleared Aug 28, 2023
Alveoair Digital Spirometer
K222525 · BZG
Roundworks Technologies Private Limited
Anesthesiology · 371d
Cleared Aug 25, 2023
OMNI Surgical System
K232214 · MRH
Sight Sciences, Inc.
Ophthalmic · 30d
Cleared Aug 25, 2023
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K231994 · JWY
Thermo Fisher Scientific
Microbiology · 51d
Cleared Aug 25, 2023
Montage-QS Settable, Resorbable Bone Putty
K231903 · MQV
Orthocon, Inc.
Orthopedic · 58d
Cleared Aug 25, 2023
Polaris Bipolar Electrosurgical Generator (29-1000)
K231872 · GEI
Kirwan Surgical Products, LLC
General & Plastic Surgery · 60d
Cleared Aug 25, 2023
NovoFine® Plus
K231255 · FMI
Novo Nordisk, Inc.
General Hospital · 116d
Cleared Aug 25, 2023
Non absorbable Surgical Polyester Suture
K231183 · GAT
Shandong Haidike Medical Products...
General & Plastic Surgery · 121d