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
19921–19944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2020
Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant
K200602 · NUC
CC Wellness, LLC
Obstetrics & Gynecology · 86d
Cleared Jun 03, 2020
Agilis HisPro Steerable Catheter With Electrodes
K200721 · DQY
Abbott (St. Jude Medical)
Cardiovascular · 76d
Cleared Jun 03, 2020
Thales 3D Mr Scanner
K200907 · IYE
Lap GmbH Laser Applikationen
Radiology · 58d
Cleared Jun 03, 2020
Hair Growth System
K200929 · OAP
Xuzhou Kernel Medical Equipment Co.,...
General & Plastic Surgery · 57d
Cleared Jun 03, 2020
QLAB Advanced Quantification Software
K200974 · QIH
Philips Health Care
Radiology · 51d
Cleared Jun 03, 2020
StealthStation Cranial Software v1.3.0
K201175 · HAW
Medtronic Navigation, Inc.
Neurology · 33d
Cleared Jun 02, 2020
Bunny Wax Personal Lubricant
K192779 · NUC
Reoxcyn, LLC
Obstetrics & Gynecology · 246d
Cleared Jun 02, 2020
HIP7
K193307 · OLO
Brainlab AG
Orthopedic · 186d
Cleared Jun 02, 2020
DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile...
K193438 · HBL
Pro-Med Instruments GmbH
Neurology · 174d
Cleared Jun 02, 2020
F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora...
K200089 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 139d
Cleared Jun 02, 2020
Altus Spine Pedicle Screw System
K200322 · NKB
Altus Partners, LLC
Orthopedic · 113d
Cleared CT Jun 02, 2020
Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A)...
K200528 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 92d
Cleared Jun 02, 2020
StarPore
K200532 · JOF
Anatomics Pty, Ltd.
Ear, Nose, Throat · 92d
Cleared Jun 02, 2020
gastroduodenal FTRD Set
K200684 · PKL
Ovesco Endoscopy AG
Gastroenterology & Urology · 78d
Cleared Jun 02, 2020
iMac 27 & PL 4.0
K200889 · PGY
Quantum-Spectra, LLC
Radiology · 60d
Cleared Jun 02, 2020
MIRA Adapter
K200911 · HRN
Phakos
Ophthalmic · 57d
Cleared Jun 02, 2020
1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil
K201101 · MOS
Neocoil, LLC
Radiology · 39d
Cleared Jun 02, 2020
MI View&GO
K201202 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Jun 01, 2020
Vitls Platform
K191620 · DRG
Vitls, Inc.
Cardiovascular · 349d
Cleared Jun 01, 2020
uWS-MR
K192601 · QIH
Shanghai United Imaging Healthcare...
Radiology · 255d
Cleared Jun 01, 2020
UNI*FUSE Infusion System with Cooper Wire
K192864 · QEY
AngioDynamics, Inc.
Cardiovascular · 238d
Cleared Jun 01, 2020
Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
K193077 · JOH
Covidien
Anesthesiology · 209d
Cleared Jun 01, 2020
XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
K193319 · HKI
Vasoptic Medical, Inc.
Ophthalmic · 182d
Cleared Jun 01, 2020
ProCell Surgical Sponge-Blood Recovery Unit
K193361 · CAC
Procell Surgical, Inc.
Cardiovascular · 180d