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
11545–11568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2022
ANNE Pediatric
K221530 · DRG
Sibel, Inc.
Cardiovascular · 180d
Cleared Nov 22, 2022
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam...
K221608 · QKZ
Anx Robotica Corp
Gastroenterology & Urology · 172d
Cleared Nov 22, 2022
Avenda Health AI Prostate Cancer Planning Software
K221624 · POK
Avenda Health, Inc.
Radiology · 169d
Cleared Nov 22, 2022
HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global...
K221704 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 162d
Cleared Nov 22, 2022
CINA
K221716 · QAS
Avicenna.Ai
Radiology · 162d
Cleared Nov 22, 2022
LED Light Therapy Mask (model: MK66R-B)
K221946 · OHS
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 140d
Cleared Nov 22, 2022
aprevo® anterior lumbar interbody fusion device with interfixation
K222009 · OVD
Carlsmed, Inc.
Orthopedic · 138d
Cleared Nov 22, 2022
VitroPRO
K222052 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 133d
Cleared Nov 22, 2022
Denti.AI Auto-Chart
K222054 · LLZ
Denti.Ai Technology, Inc.
Radiology · 133d
Cleared Nov 22, 2022
GUS610 Blood pressure monitor
K222160 · DXN
Globalcare Medical Technology Co., Ltd.
Cardiovascular · 125d
Cleared Nov 22, 2022
Cala kIQ
K222237 · QBC
Cala Health, Inc.
Neurology · 119d
Cleared Nov 22, 2022
DynamicIQ
K222895 · KPS
GE Medical Systems SCS
Radiology · 60d
Cleared Nov 22, 2022
BioPoly Lesser Toe Hemiarthroplasty Implant
K222964 · KWD
BioPoly, LLC
Orthopedic · 56d
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