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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13417–13440 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 2022
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
K213388 · QEZ
AngioDynamics, Inc.
Cardiovascular · 172d
Cleared Apr 04, 2022
Invictus® Spinal Fixation System
K214006 · NKB
Alphatec Spine, Inc.
Orthopedic · 103d
Cleared Apr 04, 2022
TRATE Dental Implant System
K220022 · DZE
Trate AG
Dental · 89d
Cleared Apr 03, 2022
ELAZ Nitrile Powder Free Examination Glove
K213604 · LZA
Protect Gloves Co., Ltd.
General Hospital · 139d
Cleared Apr 03, 2022
Medical Nitrile Examination Gloves
K220066 · LZA
Hunan Zhenheyikang Medical Instrument...
General Hospital · 83d
Cleared Apr 02, 2022
Trinity Plus Wrinkle Reducer
K212947 · OHS
Carol Cole Company Dba Nuface
General & Plastic Surgery · 199d
Cleared Apr 02, 2022
Nitrile Examination Gloves
K220343 · LZA
Nb Medical Co., Ltd.
General Hospital · 54d
Cleared Apr 01, 2022
Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and...
K210052 · FDF
Saneso, Inc.
Gastroenterology & Urology · 448d
Cleared Apr 01, 2022
LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber
K210558 · NVP
Thayer Medical Corporation
Anesthesiology · 400d
Cleared Apr 01, 2022
HD-550 Video Endoscope System
K211882 · NWB
Sonoscape Medical Corp.
Gastroenterology & Urology · 284d
Cleared Apr 01, 2022
TENS and EMS Stimulation (OTC)
K212184 · NUH
Changsha Yuwen Medical Equipment Co.,...
Neurology · 262d
Cleared Apr 01, 2022
Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
K212216 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 259d
Cleared Apr 01, 2022
Intri24 Sheath
K212392 · DYB
Inari Medical, Inc.
Cardiovascular · 242d
Cleared Apr 01, 2022
Dakota ALIF System
K213118 · OVD
Precision Spine, Inc.
Orthopedic · 186d
Cleared Apr 01, 2022
MIS Angulated multi-unit abutments
K213432 · NHA
Dentsply Sirona
Dental · 161d
Cleared Apr 01, 2022
Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
K213490 · MHX
Ge Medical Systems Information...
Cardiovascular · 151d
Cleared Apr 01, 2022
Aveir Retrieval Catheter
K213494 · MMX
Abbott Medical
Cardiovascular · 151d
Cleared Apr 01, 2022
PuraStat-RM
K213552 · PHN
3-D Matrix, Inc.
Gastroenterology & Urology · 144d
Cleared Apr 01, 2022
DEEPVESSEL FFR
K213657 · PJA
Keyamed Na, Inc.
Cardiovascular · 133d
Cleared Apr 01, 2022
EMPOWR Revision Knee
K213793 · JWH
Encore Medical, L.P.
Orthopedic · 116d
Cleared Apr 01, 2022
TENS & PMS Unit
K220005 · NUH
Shenzhen Yuehua Xinsen Technology...
Neurology · 87d
Cleared Apr 01, 2022
MAGNETOM Avanto Fit
K220151 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 72d
Cleared Apr 01, 2022
SKANRAD 400
K220518 · KPR
Skanray Technologies Limited
Radiology · 37d
Cleared Apr 01, 2022
CoolTone
K220601 · NGX
Zimmer Medizinsysteme GmbH
Physical Medicine · 30d