FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
12817–12840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 2022
SURGIVISIO Device
K221028 · OLO
Ecential Robotics
Orthopedic · 90d
Cleared Jul 06, 2022
UniPrime A, UniPrime E, UniPrime E/C
K221033 · KLE
S&C Polymer Silicon- Und Composite...
Dental · 90d
Cleared Jul 06, 2022
Surgical Mask (Model: 0868F, 0866F)
K221173 · FXX
Jiangxi Sanhao Medical Instruments...
General Hospital · 72d
Cleared Jul 06, 2022
Functional MR V1.0
K221426 · LLZ
Olea Medical S.A.S.
Radiology · 51d
Cleared Jul 05, 2022
SleepCheckRx
K213360 · MNR
Resapp Health
Anesthesiology · 266d
Cleared Jul 05, 2022
CediTEC
K220743 · EBI
Voco GmbH
Dental · 113d
Cleared Jul 05, 2022
Electric Wheelchair
K220827 · ITI
Foshan Dahao Medical Technology Co.,...
Physical Medicine · 105d
Cleared Jul 05, 2022
Osteon Precision Milled Suprastructure
K221019 · NHA
Implant Solutions Pty Ltd (Aka Osteon...
Dental · 90d
Cleared Jul 05, 2022
Materialise TKA Guide System
K221337 · JWH
Materialise NV
Orthopedic · 57d
Cleared Jul 01, 2022
Hanger Cranial Band 3D
K203134 · MVA
Symbion Logistics, LLC
Neurology · 620d
Cleared Jul 01, 2022
BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle
K211085 · BSP
Becton, Dickinson and Company
Anesthesiology · 445d
Cleared Jul 01, 2022
Dental diode laser, SOGA Laser, ILaser II
K211150 · NVK
Shenzhen Soga Technology Co., Ltd.
Dental · 438d
Cleared Jul 01, 2022
Smith & Nephew Hip Systems
K211176 · LPH
Smith & Nephew, Inc.
Orthopedic · 437d
Cleared Jul 01, 2022
NovaCore Semi-Automatic Biopsy Instrument
K213232 · KNW
Argon Medical Devices
General & Plastic Surgery · 274d
Cleared Jul 01, 2022
CROSSLEAD Peripheral Guide Wire
K213315 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 270d
Cleared Jul 01, 2022
GEM
K213385 · KRD
Obsidio, Inc.
Cardiovascular · 261d
Cleared Jul 01, 2022
Bladder Scanner, Model Name:M5
K213488 · IYO
Suzhou Peaksonic Medical Technology...
Radiology · 242d
Cleared Jul 01, 2022
Nihon Kohden NKV-330 Ventilator System
K213521 · MNT
Nihon Kohden Orangemed, Inc.
Anesthesiology · 240d
Cleared Jul 01, 2022
Ennovate Cervical Spinal and Occiput System
K213871 · NKG
Aesculap Implant Systems, LLC
Orthopedic · 200d
Cleared Jul 01, 2022
ENT Nasopharyngoscope and Accessories
K214050 · EOB
Medimaging Integrated Solution, Inc...
Ear, Nose, Throat · 186d
Cleared Jul 01, 2022
NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
K220171 · QTF
Northeast Scientific, Inc.
Cardiovascular · 161d
Cleared Jul 01, 2022
Home use hair removal device
K220248 · OHT
Shenzhen Mareal Tech Co., Ltd.
General & Plastic Surgery · 151d
Cleared Jul 01, 2022
CerroZone Mobile
K220298 · FRF
Cerrozone
General Hospital · 149d
Cleared Jul 01, 2022
PuraPly Micronized Wound Matrix (PuraPly MZ)
K220317 · KGN
Organogenesis, Inc.
General & Plastic Surgery · 148d