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
11833–11856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2022
iRoot BP Root Repair Material BioAggregate Paste
K222992 · KIF
Innovative Bioceramix, Inc.
Dental · 55d
Cleared Nov 22, 2022
Renasys Edge (66803126)
K223041 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 54d
Cleared Nov 22, 2022
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
K223080 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 53d
Cleared Nov 22, 2022
Vision 2, EVARVision, TrackVision 2, HeartVision 2
K223152 · LLZ
GE Medical Systems SCS
Radiology · 47d
Cleared Nov 21, 2022
Implanter incl. Accessories
K211358 · EBW
Guilin Woodpecker Medical Instrument...
Dental · 567d
Cleared Nov 21, 2022
Vision Monitor- MonCvONE
K212936 · GWE
Metrovision
Ophthalmic · 432d
Cleared Nov 21, 2022
CORE-SNARE
K220846 · FDI
Incore Co., Ltd.
Gastroenterology & Urology · 243d
Cleared Nov 21, 2022
Infusion Sets for Single Use with Needles
K221069 · FPA
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 223d
Cleared Nov 21, 2022
Infusion Sets for Single Use
K221075 · FPA
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 223d
Cleared Nov 21, 2022
Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use
K221078 · FPA
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 223d
Cleared Nov 21, 2022
SR-1 Skin Treatment System
K221268 · ONG
Avava, Inc.
General & Plastic Surgery · 203d
Cleared Nov 21, 2022
Vista BC Sealer
K221811 · KIF
Inter-Med, Inc.
Dental · 152d
Cleared Nov 21, 2022
Disposable Sterile Lancet
K222246 · QRL
Tianjin Rilifine Medical Device Co.,...
General & Plastic Surgery · 118d
Cleared Nov 21, 2022
Kowa SL-19
K222372 · HJO
Kowa Company , Ltd.
Ophthalmic · 108d
Cleared Nov 21, 2022
Flex-Thread™ Ulna Intramedullary Nail System
K222390 · HSB
Flower Orthopedics Corporation Dba...
Orthopedic · 105d
Cleared Nov 21, 2022
Disposable Blood Pressure Cuff
K222420 · DXQ
Wenzhou Xikang Medical Instruments...
Cardiovascular · 102d
Cleared Nov 21, 2022
Treace Medical Concepts (TMC) Implant Fixation System
K222645 · JDR
Treace Medical Concepts
Orthopedic · 81d
Cleared Nov 21, 2022
SM-V
K222951 · IZL
Sedecal., Sa.
Radiology · 55d
Cleared Nov 21, 2022
Pentax Medical Valve Set
K222980 · ODC
Yangzhou Fartley Medical Instrument...
Gastroenterology & Urology · 54d
Cleared Nov 21, 2022
SIS System (Version 5.6.0)
K223032 · QIH
Surgical Information Sciences, Inc.
Radiology · 53d
Cleared Nov 21, 2022
Miro3D Wound Matrix
K223257 · KGN
Reprise Biomedical
General & Plastic Surgery · 31d
Cleared Nov 20, 2022
Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use...
K221165 · LZA
Sri Trang Gloves (Thailand) Public...
General Hospital · 212d
Cleared Nov 20, 2022
Empatica Health Monitoring Platform
K221282 · DQA
Empatica S.R.L.
Anesthesiology · 201d
Cleared Nov 18, 2022
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
K210623 · DFH
Sebia
Immunology · 626d