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
25753–25776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2018
Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
K181207 · NUH
Everyway Medical Instruments Co., Ldt.
Neurology · 30d
Cleared Jun 05, 2018
ImmuGlo HEp-2 Elite IFA
K172745 · DHN
Immco Diagnostics, Inc.
Immunology · 266d
Cleared Jun 05, 2018
Oximeter
K173045 · DQA
Shenzhen Greatmade Tech Limited
Anesthesiology · 250d
Cleared Jun 05, 2018
TAMA BEMS device
K173093 · NFO
Tama Research Corporation
Neurology · 249d
Cleared Jun 05, 2018
LungQ Software
K173821 · JAK
Thirona Corporation
Radiology · 169d
Cleared Jun 05, 2018
Straumann BLX Implant System
K173961 · DZE
Institut Straumann AG
Dental · 159d
Cleared Jun 05, 2018
SuperBall Meniscal Repair System
K180191 · GAT
Arcuro Medical , Ltd.
General & Plastic Surgery · 133d
Cleared Jun 05, 2018
Vbeam Prima Laser System
K180593 · GEX
Syneron-Candela
General & Plastic Surgery · 91d
Cleared CT Jun 05, 2018
Lunoa System
K180608 · MYB
Nightbalance BV
Ear, Nose, Throat · 90d
Cleared Jun 05, 2018
SIGMA Sterilization Pouch and Roll
K180661 · FRG
Sigma Medical Supplies Corp.
General Hospital · 83d
Cleared Jun 04, 2018
Check-Flo Performer Introducer Micropuncture Radial Artery Access Set
K171609 · DYB
Cook Incorporated
Cardiovascular · 368d
Cleared Jun 04, 2018
Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting...
K172763 · JKA
Zhejiang Kindly Medical Devices Co.,...
General Hospital · 264d
Cleared Jun 04, 2018
Silicone Foley Catheter for single use
K172807 · EZL
Changzhou Rongxin Medicine Minimal...
Gastroenterology & Urology · 259d
Cleared Jun 04, 2018
reVive Light Therapy LED Cleansing System
K180447 · OLP
Led Technologies, Inc.
General & Plastic Surgery · 104d
Cleared Jun 04, 2018
VariAx 2 System
K180500 · HWC
Stryker GmbH
Orthopedic · 98d
Cleared Jun 04, 2018
SmartClip Soft Tissue Marker
K180640 · NEU
Elucent Medical, Inc.
General & Plastic Surgery · 84d
Cleared Jun 04, 2018
BUHLMANN fCAL ELISA
K181012 · NXO
Buhlmann Laboratories AG
Immunology · 48d
Cleared Jun 01, 2018
Silverwear Silver Pro Garment Device
K171798 · GXY
Media Plus, LLC
Neurology · 350d
Cleared Jun 01, 2018
Kenz Cardico1211
K172068 · DPS
Suzuken Co., Ltd.
Cardiovascular · 329d
Cleared Jun 01, 2018
Oxygen Concentrator
K172234 · CAW
Sysmed (China) Co., Ltd.
Anesthesiology · 311d
Cleared Jun 01, 2018
Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss...
K172410 · BSP
Smiths Medical Asd, Inc.
Anesthesiology · 296d
Cleared Jun 01, 2018
NEOSHIELD
K172499 · ONB
JMS North America Corporation
General Hospital · 287d
Cleared Jun 01, 2018
Smart Moves Complete
K172765 · NXC
Great Lakes Orthodontics, Ltd.
Dental · 261d
Cleared Jun 01, 2018
PanNAT STEC Test
K173330 · PCI
Micronics, Inc.
Microbiology · 221d