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
6625–6648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 2024
GPS Advanced
K241426 · FMF
Prosidyan, Inc.
Orthopedic · 51d
Cleared Jul 10, 2024
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance...
K240666 · DTZ
Medtronic Perfusion Systems
Cardiovascular · 124d
Cleared Jul 10, 2024
Sentio Ti Implant Kit
K240614 · PFO
Oticon Medical AB
Ear, Nose, Throat · 127d
Cleared Jul 10, 2024
HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
K240527 · NEU
Devicor Medical Products, Inc.
General & Plastic Surgery · 138d
Cleared Jul 10, 2024
IPL Hair Removal Device (YT01,YT02,YT03,YT04)
K240016 · OHT
Shenzhen Jianrong Biomedical...
General & Plastic Surgery · 190d
Cleared Jul 10, 2024
AOS Interstitial Templates, Needles, and Accessories
K233628 · JAQ
Alpha-Omega Services, Inc.
Radiology · 240d
Cleared Jul 10, 2024
Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit
K233453 · QQX
Life Technologies Corporation
Microbiology · 264d
Cleared Jul 10, 2024
Lightin System, Lightin, Lightin Generator
K232177 · SBS
Solmedix Co., Ltd.
Ear, Nose, Throat · 352d
Cleared Jul 09, 2024
Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™
K241372 · MTD
Abbott Medical
Cardiovascular · 55d
Cleared Jul 09, 2024
IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130,...
K241343 · OHT
Shenzhen Lescolton Electrical...
General & Plastic Surgery · 57d
Cleared Jul 09, 2024
Zirconia Block
K241316 · EIH
Hunan Hualian Special Ceramics Co., Ltd.
Dental · 60d
Cleared Jul 09, 2024
aprevo® TLIF-C Articulating System
K241019 · MAX
Carlsmed
Orthopedic · 85d
Cleared Jul 09, 2024
Prima Plus Conical Implant System
K240966 · DZE
Keystone Dental, Inc.
Dental · 91d
Cleared Jul 09, 2024
deepLive
K240610 · NQQ
Damae Medical
General & Plastic Surgery · 126d
Cleared Jul 09, 2024
OW100S
K233937 · PZL
Softwave/Trt, LLC
General & Plastic Surgery · 208d
Cleared Jul 09, 2024
EM-07 Cordless Endo Motor
K232551 · EKX
Forum Engineering Technologies (96) ,...
Dental · 321d
Cleared Jul 08, 2024
LED Light Therapy Device, ELIXIR MD™
K241293 · GEX
Yassen Wellness, LLC
General & Plastic Surgery · 61d
Cleared Jul 08, 2024
da Vinci SP Surgical System (SP1098)
K240502 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 138d
Cleared Jul 08, 2024
RhythmStar System
K233584 · QYX
RhythMedix, LLC
Cardiovascular · 244d
Cleared Jul 05, 2024
SiOxD® Wound Matrix
K241660 · QSZ
Sioxmed, LLC
General & Plastic Surgery · 25d
Cleared Jul 05, 2024
DUO1 and DUO2
K241649 · MUH
Zinnovi, Inc.
Radiology · 28d
Cleared Jul 05, 2024
Anatase Navi Disposable Instrument
K241625 · OLO
Remex Medical Corp.
Orthopedic · 29d
Cleared Jul 05, 2024
LifeRay Intraoral Handheld X-ray System
K241305 · EHD
Lucas Lifecare
Radiology · 57d
Cleared Jul 05, 2024
AMT Suture Passer
K241111 · GCJ
Applied Medical Technology, Inc.
General & Plastic Surgery · 74d