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
12361–12384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 2022
CogNet QmTRIAGE
K220080 · QFM
Medcognetics, Inc.
Radiology · 262d
Cleared Sep 29, 2022
Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S,...
K221300 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 147d
Cleared Sep 29, 2022
CureSight-CS100
K221375 · QQU
Novasight , Ltd.
Ophthalmic · 140d
Cleared Sep 29, 2022
Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S,...
K221496 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 129d
Cleared Sep 29, 2022
Surgical Gown (Sterile)
K221637 · FYA
Allmed Medical (Hubei) Protective...
General Hospital · 115d
Cleared Sep 29, 2022
ReFlow System Mini
K221918 · JXG
Anuncia Medical, Inc.
Neurology · 90d
Cleared Sep 29, 2022
S.I.N. Instrument Kits
K222005 · KCT
S.I.N. ? Sistema DE Implante Nacional...
General Hospital · 84d
Cleared Sep 29, 2022
GM85
K222353 · IZL
Samsung Electronics Co., Ltd.
Radiology · 56d
Cleared Sep 29, 2022
Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX...
K222383 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 55d
Cleared Sep 29, 2022
iFuse TORQ® Implant System
K222605 · OUR
SI-BONE, Inc.
Orthopedic · 31d
Cleared Sep 29, 2022
Digital Radiography CXDI-Elite, Digital Radiography E1
K222687 · MQB
Canon, Inc.
Radiology · 23d
Cleared Sep 28, 2022
InnovaMatrix PD
K211902 · KGN
Triad Life Sciences, Inc.
General & Plastic Surgery · 464d
Cleared Sep 28, 2022
Neteera 130H/131H Vital Sign Monitoring Sensor
K212143 · DRT
Neteera Technologies , Ltd.
Cardiovascular · 446d
Cleared Sep 28, 2022
CORE-SPORT
K220081 · OTJ
Incore Co., Ltd.
General & Plastic Surgery · 261d
Cleared Sep 28, 2022
Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
K220245 · KNG
Contec Medical Systems Co.,Ltd
Obstetrics & Gynecology · 243d
Cleared Sep 28, 2022
MitraClip G4 Steerable Guide Catheter
K221397 · DRA
Abbott Medical
Cardiovascular · 138d
Cleared Sep 28, 2022
Dental Air Polishing Handpiece
K221548 · EFB
Guilin Woodpecker Medical Instrument...
Dental · 124d
Cleared Sep 28, 2022
TROJAN Fire & Ice lubricated male natural rubber latex condom
K221906 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 90d
Cleared Sep 28, 2022
IPL Hair Removal Device
K222316 · OHT
Shenzhen Goodwind Technology...
General & Plastic Surgery · 57d
Cleared Sep 28, 2022
SteriCUBE® Multiple Tray Sterilization Systems
K222328 · KCT
Stericube, LLC
General Hospital · 57d
Cleared Sep 28, 2022
BriefCase
K222329 · QAS
Aidoc Medical , Ltd.
Radiology · 57d
Cleared Sep 28, 2022
DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
K222442 · LYZ
Anhui Bytech Medical Supplies Co., Ltd.
General Hospital · 47d
Cleared Sep 28, 2022
AGILON XO Shoulder System
K222482 · KWT
Implantcast GmbH
Orthopedic · 42d
Cleared Sep 28, 2022
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid...
K222615 · MED
STERIS Corporation
General Hospital · 29d