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
5401–5424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 2024
TACTIX Vector Syndesmosis System
K243408 · HTN
Vilex, LLC
Orthopedic · 26d
Cleared Nov 27, 2024
SmoothSkin Pure Switch (SSC1)
K243362 · OHT
Cyden Limited
General & Plastic Surgery · 29d
Cleared Nov 27, 2024
Ceragem Automatic Thermal Massager (CGM-MB-1902)
K243355 · JFB
Ceragem Co., Ltd.
Physical Medicine · 29d
Cleared Nov 27, 2024
Remunity System
K243354 · QJY
Deka Research & Development Corp.
General Hospital · 29d
Cleared Nov 27, 2024
RadiForce RX570
K243221 · PGY
Eizo Corporation
Radiology · 51d
Cleared Nov 27, 2024
CryoGlow (FW3XXXX)
K242796 · OHS
Sharkninja Operating, LLC
General & Plastic Surgery · 72d
Cleared Nov 27, 2024
LED Light Therapy Machine (G1, G3, G4, G6)
K242638 · OHS
Shenzhen Walton Technology Co., Ltd.
General & Plastic Surgery · 85d
Cleared Nov 27, 2024
HERA W10 Diagnostic Ultrasound System
K242444 · IYN
Samsung Medison Co., Ltd.
Radiology · 103d
Cleared Nov 27, 2024
Power wheelchair
K242308 · ITI
Zhejiang Zhonglei Medical Technology...
Physical Medicine · 114d
Cleared Nov 27, 2024
BioBrace®
K242187 · OWW
Conmed Corporation
Orthopedic · 125d
Cleared Nov 27, 2024
Pelvic Floor Stimulator (Intrelief PFE)
K241899 · KPI
Easymed Instruments Co., Ltd.
Gastroenterology & Urology · 152d
Cleared Nov 27, 2024
AirSculpt Body Contouring System (AIRS-1-SYS)
K241835 · QPB
Cellmyx
General & Plastic Surgery · 155d
Cleared Nov 27, 2024
PowerLoc™ Max Power Injectable Infusion Set
K241353 · PTI
Bard Access Systems, Inc.
General Hospital · 198d
Cleared Nov 27, 2024
SV Spectrum MRC Central Venous Catheter
K241115 · FOZ
Spectrum Vascular
General Hospital · 218d
Cleared Nov 27, 2024
Nexpowder
K240994 · QAU
Nextbiomedical Co., Ltd.
General & Plastic Surgery · 230d
Cleared Nov 27, 2024
Sonix Health
K240645 · QIH
Ontact Health Co., Ltd.
Radiology · 265d
Cleared Nov 27, 2024
C&B Ceramic
K233273 · EBF
Prevest Denpro Limited
Dental · 425d
Cleared Nov 26, 2024
Cross Wise™ Multi-Use RF Adapter Cable
K243193 · DXF
Circa Scientific, Inc.
Cardiovascular · 57d
Cleared Nov 26, 2024
Atlas Spine Lateral Expandable Interbody System
K243191 · OVD
Atlas Spine, Inc.
Orthopedic · 57d
Cleared Nov 26, 2024
Arm Blood Pressure Monitor (model: BPM-A7VL)
K243118 · DXN
Shenzhen Imdk Medical Technology Co.,...
Cardiovascular · 57d
Cleared Nov 26, 2024
TriMed Posterior Malleolus Fixation System
K243050 · HRS
TriMed, Inc.
Orthopedic · 60d
Cleared Nov 26, 2024
Intraluminal Applicator Set
K242961 · JAQ
Varian Medical Systems
Radiology · 62d
Cleared Nov 26, 2024
RadUnity (Version 1.0.0)
K242810 · LLZ
Radunity Corp.
Radiology · 69d
Cleared Nov 26, 2024
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242657 · JWY
Thermo Fisher Scientific
Microbiology · 83d