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
16633–16656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 2021
NuVasive Pulse System
K210574 · OLO
Nu Vasive, Incorporated
Orthopedic · 153d
Cleared Jul 29, 2021
Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor
K210770 · DXN
Andon Health Co, Ltd.
Cardiovascular · 136d
Cleared Jul 29, 2021
Hemafuse System
K210862 · CAC
Sisu Global Health
Cardiovascular · 128d
Cleared Jul 29, 2021
SMART Taylor Spatial Frame
K210953 · KTT
Smith & Nephew, Inc.
Orthopedic · 121d
Cleared Jul 29, 2021
Disposable Nitrile Medical Examination Glove
K211131 · LZA
Siyang Threeguard Medical Supplies...
General Hospital · 104d
Cleared Jul 29, 2021
Vinyl compound examination gloves
K211229 · LYZ
Hebei Titans Hongsen Medical...
General Hospital · 97d
Cleared Jul 29, 2021
OCS Lung Solution
K211314 · MSB
TransMedics, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 29, 2021
CRUXVIEW
K211317 · MUH
Cruxell Corp.
Radiology · 90d
Cleared Jul 29, 2021
Blue Nitrile Exam Gloves
K211341 · LZA
Jiangxi Surefine Medical Co., Ltd.
General Hospital · 87d
Cleared Jul 29, 2021
Zap-X Radiosurgical System
K211663 · IYE
Zap Surgical Systems, Inc.
Radiology · 58d
Cleared Jul 29, 2021
GMK Sphere Revision
K211664 · JWH
Medacta International S.A.
Orthopedic · 58d
Cleared Jul 28, 2021
Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular...
K201657 · LZO
Corin, Ltd.
Orthopedic · 405d
Cleared Jul 28, 2021
BD Flu+ Syringe
K203359 · FMF
Becton, Dickinson and Company
General Hospital · 254d
Cleared Jul 28, 2021
Disposable Ear Thermometer Probe Cover
K203431 · FLL
Huaian Zhongxin Packing Material Co.,...
General Hospital · 247d
Cleared Jul 28, 2021
Pac-Dent Denture Base Resin
K210189 · EBI
Pac-Dent, Inc.
Dental · 184d
Cleared Jul 28, 2021
Broncho Videoscope System
K210379 · EOQ
Scivita Medical Technology Co., Ltd.
Ear, Nose, Throat · 169d
Cleared Jul 28, 2021
Disposable Surgical Face Mask
K210409 · FXX
Shandong Zhushi Pharmaceutical Group...
General Hospital · 167d
Cleared Jul 28, 2021
Purism Disposable Surgical Mask
K210856 · FXX
Chuzhou Daddy'S Choice Science and...
General Hospital · 127d
Cleared Jul 28, 2021
Portray
K211014 · EHD
Surround Medical Systems
Radiology · 114d
Cleared Jul 28, 2021
Neocis Guidance System (NGS) with Intraoral Fiducial Array
K211129 · PLV
Neocis, Inc.
Dental · 103d
Cleared Jul 28, 2021
MIS Ti-base abutment
K211225 · NHA
Dentsply Sirona
Dental · 96d
Cleared Jul 28, 2021
Diode Laser Machine, Model Number: BM-100
K211335 · GEX
Zhengzhou Bestview ST Co., Ltd.
General & Plastic Surgery · 86d
Cleared Jul 28, 2021
NIO-I
K211395 · FMI
Einstein Works, LLC
General Hospital · 84d
Cleared Jul 28, 2021
Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and...
K211455 · LZA
Shen Wei (Usa), Inc.
General Hospital · 79d