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
9385–9408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 2023
Ventrax™ Delivery System (VTR851)
K231246 · DQY
Merit Medical Systems, Inc.
Cardiovascular · 121d
Cleared Aug 30, 2023
Enzyme Packed Cartridge - RELiZORB
K231156 · PLQ
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 128d
Cleared Aug 30, 2023
Phoenix Contact Lens Case - dome top flat pack (CL-01)
K231123 · LRX
Phoenix Innovative Healthcare...
Ophthalmic · 132d
Cleared Aug 30, 2023
AlphaVent Suture Anchors
K231093 · MBI
Stryker Endoscopy
Orthopedic · 134d
Cleared Aug 30, 2023
AquaBeam Robotic System
K231024 · PZP
Procept Biorobotics, Corporation
Gastroenterology & Urology · 141d
Cleared Aug 30, 2023
Arrow Non-Stimulating SnapLock Adapter (K-05520-005C)
K230603 · BSO
Teleflex Medical
Anesthesiology · 180d
Cleared Aug 30, 2023
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
K230355 · LNH
Canon Medical Systems Corporation
Radiology · 202d
Cleared Aug 30, 2023
Mick Valencia Applicator Set
K230155 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 223d
Cleared Aug 30, 2023
Silk'n Titan Allways
K230013 · PAY
Silk'N Beauty , Ltd.
General & Plastic Surgery · 239d
Cleared Aug 30, 2023
Nexis® compressive screws
K223468 · HWC
Novastep
Orthopedic · 286d
Cleared Aug 30, 2023
Ochsner Connected Inhaler Sensor
K223367 · CAF
Ochsner Clinic Foundation
Anesthesiology · 299d
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