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

Filters: Cleared only ×
175,820 results
29545–29568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2017
Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module
K161469 · FRN
Hospira, Inc.
General Hospital · 305d
Cleared Mar 28, 2017
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
K161816 · MDB
bioMerieux, Inc.
Microbiology · 270d
Cleared Mar 28, 2017
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs...
K162405 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 211d
Cleared Mar 28, 2017
Foresight Intracardiac Echocardiology (ICE) System
K162789 · DQO
Conavi Medical, Inc.
Cardiovascular · 175d
Cleared Mar 28, 2017
MR8 Drill System
K163565 · HBC
Medtronic Powered Surgical Solutions
Neurology · 99d
Cleared Mar 28, 2017
Nio Color 5.8MP (MDNC-6121)
K170476 · PGY
Barco N.V.
Radiology · 40d
Cleared Mar 28, 2017
HS50 / HS60 Diagnostic Ultrasound System
K170493 · IYN
Samsung Medison Co., Ltd.
Radiology · 39d
Cleared Mar 27, 2017
Sapphire Infusion Pump
K161667 · FRN
Q Core Medical , Ltd.
General Hospital · 284d
Cleared Mar 27, 2017
Cleveland Multiport Ventricular Catheter Set
K161731 · HCA
Parker Hannifin Corp.
Neurology · 277d
Cleared Mar 27, 2017
Freedom Syringe
K161812 · FMF
Procedure Products, Inc.
General Hospital · 269d
Cleared Mar 27, 2017
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K163248 · EOQ
Boston Scientific Corporation
Ear, Nose, Throat · 129d
Cleared Mar 25, 2017
Silk'n HST
K162784 · OHS
Home Skinovations , Ltd.
General & Plastic Surgery · 173d
Cleared Mar 24, 2017
K3PRO Konus Additional Abutments and Implants
K160581 · DZE
Argon Med. Productions Vertriebs...
Dental · 388d
Cleared Mar 24, 2017
MEDICON Spinal Spreading Systems
K161680 · GZT
Medicon EG
Neurology · 280d
Cleared Mar 24, 2017
iovera system
K161835 · GXH
Myoscience, Inc.
Neurology · 262d
Cleared Mar 24, 2017
CardioDay V2.5
K162023 · DQK
Getemed Medizin- Und...
Cardiovascular · 245d
Cleared Mar 24, 2017
PREMIUM - SHELTA Prosthetic Components
K162028 · NHA
Sweden & Martina S.P.A.
Dental · 245d
Cleared Mar 24, 2017
LUVENA VAGINAL MOISTURIZER & LUBRICANT
K162235 · NUC
Laclede, Inc.
Obstetrics & Gynecology · 227d
Cleared Mar 24, 2017
Stellaris Elite Vision Enhancement System
K162342 · HQC
Bausch & Lomb
Ophthalmic · 214d
Cleared Mar 24, 2017
Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software
K162503 · DSH
Cardiac Insight, Inc.
Cardiovascular · 198d
Cleared Mar 24, 2017
LIGHTFUSION LED SYSTEM
K162556 · GEX
Vitage Led, Ltd.
General & Plastic Surgery · 191d
Cleared Mar 24, 2017
Mould Applicator Set
K162615 · JAQ
Varian Medical Systems, Inc.
Radiology · 186d
Cleared Mar 24, 2017
VERIFY Assert Self-Contained Biological Indicator
K162701 · OWP
STERIS Corporation
General Hospital · 177d
Cleared Mar 24, 2017
GuideMia Ortho+
K162850 · PNN
Guidemia Technologies, LLC
Dental · 164d