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
11617–11640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 2022
Accure Laser
K222109 · GEX
Accure Acne, Inc.
General & Plastic Surgery · 122d
Cleared Nov 17, 2022
Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
K222208 · PGY
Qingdao Hisense Medical Equipment...
Radiology · 115d
Cleared Nov 17, 2022
OmegaAI Image Viewer
K222476 · LLZ
Ramsoft, Inc.
Radiology · 93d
Cleared Nov 17, 2022
FX Contra
K222518 · EGS
Nakanishi, Inc.
Dental · 90d
Cleared Nov 17, 2022
IPL Hair Removal Device
K222598 · OHT
Shenzhen Noble Smart Manufacturing...
General & Plastic Surgery · 80d
Cleared Nov 17, 2022
Alexandrite and Nd:YAG Laser models CANLASE and TORLASE
K222673 · GEX
Canadian Pioneer Medical Technology...
General & Plastic Surgery · 72d
Cleared Nov 17, 2022
IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti...
K222973 · ODP
Alphatec Spine, Inc.
Orthopedic · 50d
Cleared Nov 17, 2022
MAVEN™ Patient-Specific Instrumentation
K223227 · HSN
Paragon 28, Inc.
Orthopedic · 30d
Cleared Nov 17, 2022
SKR 3000
K223267 · MQB
Konica Minolta, Inc.
Radiology · 24d
Cleared Nov 17, 2022
easy Claire
K223278 · OHS
Y & J Bio Co., Ltd.
General & Plastic Surgery · 24d
Cleared Nov 16, 2022
KNH Surgical Face Mask
K203528 · FXX
Knh Surgical Face Mask
General Hospital · 714d
Cleared Nov 16, 2022
Surgical Gown
K212812 · FYA
Xianning Marveldas Protective...
General Hospital · 439d
Cleared Nov 16, 2022
Disposable surgical face mask
K220302 · FXX
Shandong Aida Medical Products Co., Ltd.
General Hospital · 287d
Cleared Nov 16, 2022
PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX...
K220465 · EOB
Pentax of America, Inc.
Ear, Nose, Throat · 272d
Cleared Nov 16, 2022
Endoscopy Oxygen Mask
K220533 · CCK
Engineered Medical Systems, Inc.
Anesthesiology · 265d
Cleared Nov 16, 2022
Heater-Cooler System 3T
K220635 · DWC
Livanova Deutschland, GmbH
Cardiovascular · 257d
Cleared Nov 16, 2022
PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection...
K220841 · DZE
Dentsply Sirona
Dental · 238d
Cleared Nov 16, 2022
OmniTaper EV Dental Implants, DS Implants abutments with EV connection
K221094 · DZE
Dentsply Sirona
Dental · 216d
Cleared Nov 16, 2022
BoneMRI v1.4
K221762 · QIH
Mrlguidance B.V.
Radiology · 152d
Cleared Nov 16, 2022
Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA),...
K222364 · OAP
Xtrallux, LLC
General & Plastic Surgery · 104d
Cleared Nov 16, 2022
Life Spine ALIF Buttress Plate System
K222628 · KWQ
Life Spine, Inc.
Orthopedic · 77d
Cleared Nov 15, 2022
LifeSPARC System
K211830 · QNR
Cardiacassist, Inc.
Cardiovascular · 519d
Cleared Nov 15, 2022
Omnia Medical TiBrid-SC
K212612 · OVE
Omnia Medical, LLC
Orthopedic · 455d
Cleared Nov 15, 2022
Dyflex-II
K212700 · NKB
Taeyeon Medical Co., Ltd.
Orthopedic · 447d