FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
14521–14544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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 CT 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
Cleared Apr 01, 2022
Wireless Digital Flat Panel Detector
K220668 · MQB
Iray Technology Taicang , Ltd.
Radiology · 25d
Cleared Mar 31, 2022
Elecsys proBNP II, Elecsys proBNP II STAT
K210546 · NBC
Roche Diagnostics
Chemistry · 399d
Cleared Mar 31, 2022
Alexis Contained Extraction System
K211043 · GCJ
Applied Medical Resources Corporation
Obstetrics & Gynecology · 357d
Cleared CT Mar 31, 2022
ERIC Retrieval Device
K211120 · NRY
MicroVention, Inc.
Neurology · 350d
Cleared Mar 31, 2022
Golnit Nylon Monofilament Suture
K212888 · GAR
Antarma, LLC Dba Golnit Sutures
General & Plastic Surgery · 202d
Cleared Mar 31, 2022
PhasTIPP
K212894 · DWQ
LeMaitre Vascular, Inc.
Cardiovascular · 202d
Cleared Mar 31, 2022
Medical Face Mask
K213736 · FXX
Hangzhou Runheng Medical Co., Ltd.
General Hospital · 122d
Cleared Mar 31, 2022
Air Compression Therapy Device, model: ST-502
K213745 · IRP
Shenzhen Future Electronic Co., Ltd.
Physical Medicine · 122d