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
21601–21624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 2019
HIVOX Spopad EMS SP-911, SP-921
K192264 · NGX
Hivox Biotek, Inc.
Physical Medicine · 79d
Cleared Nov 08, 2019
APTUS Wrist Arthrodesis Plates
K192297 · HRS
Medartis AG
Orthopedic · 77d
Cleared Nov 08, 2019
VK100 Percutaneous Vertebral Augmentation System
K192403 · NDN
Bonwrx, Ltd.
Orthopedic · 66d
Cleared Nov 08, 2019
IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129,...
K192432 · OHT
Shenzhen Bosidin Technology Co., Ltd.
General & Plastic Surgery · 64d
Cleared Nov 08, 2019
OEC Elite
K192819 · OXO
Ge Oec Medical Systems, Inc.
Radiology · 38d
Cleared Nov 07, 2019
StoneBite and StoneBite scan
K190571 · ELW
Dreve Dentamid GmbH
Dental · 246d
Cleared Nov 07, 2019
BioGenesis Fertility Lubricant
K190872 · PEB
Good Clean Love, Inc.
Obstetrics & Gynecology · 218d
Cleared Nov 07, 2019
Salem Sump Dual Lumen Stomach Tube with ENFit Connection
K190923 · PIF
Cardinalhealth
Gastroenterology & Urology · 212d
Cleared Nov 07, 2019
MEDIP PRO
K191026 · LLZ
Medical IP Co., Ltd.
Radiology · 203d
Cleared Nov 07, 2019
DemeDIOX Barbed Absorbable Surgical Suture
K191361 · NEW
Demetech Corporation
General & Plastic Surgery · 170d
Cleared Nov 07, 2019
SandShark Injectable Anchor (SIA) System
K191466 · GZB
Stimwave Technologies, Inc.
Neurology · 157d
Cleared Nov 07, 2019
Progenikine Concentrating System 25 mL System
K191564 · MUU
Emcyte Corporation
General & Plastic Surgery · 147d
Cleared Nov 07, 2019
Portux CAD/CAM Disc
K192153 · EBG
New Stetic, SA
Dental · 90d
Cleared Nov 07, 2019
PRECICE Plating System
K192181 · KTT
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 87d
Cleared Nov 07, 2019
DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile
K192327 · HRS
Synthes USA Products, LLC
Orthopedic · 72d
Cleared Nov 07, 2019
DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless
K192632 · MQB
Canon, Inc.
Radiology · 45d
Cleared Nov 07, 2019
B. anthracis Real-time PCR Assay
K192871 · NHT
Centers For Disease Control and...
Microbiology · 30d
Cleared Nov 07, 2019
Laparoscope Lens Shield Device (LENS)
K192891 · GCJ
Medeon Biodesign, Inc.
General & Plastic Surgery · 28d
Cleared Nov 07, 2019
EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G,...
K192948 · KNW
Bard Peripheral Vascular, Inc.
General & Plastic Surgery · 20d
Cleared Nov 06, 2019
Silicone Foley Catheter
K182463 · EZL
Biosensors International Pte, Ltd.
Gastroenterology & Urology · 422d
Cleared Nov 06, 2019
BIO-RAY A-1 Anchor Screw System
K182929 · OAT
Microware Precision Co., Ltd.
Dental · 380d
Cleared Nov 06, 2019
Vivid Aligners
K190003 · NXC
Orthodent Laboratory, Inc.
Dental · 308d
Cleared Nov 06, 2019
Hydrofera Blue READY - Border
K190268 · FRO
Hydrofera, LLC
General & Plastic Surgery · 271d
Cleared Nov 06, 2019
GSP Neonatal Total Galactose kit
K190335 · JIA
Perkinelmer, Inc.
Chemistry · 265d