Search FDA 510(k) Devices

5,435 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2021–2021 ×
3,023 results
1441–1464 of 3,023
Cleared Jul 24, 2021
Disposable Vinyl Nitrile Synthetic Gloves Powder Free
K211262 · LYZ
Tangshan Hongyun Healthcare Products...
General Hospital · 89d
Cleared Jul 23, 2021
HMB32 Dialysis Solution
K212052 · KPO
Haemopharm Biofluids S.R.L.
Gastroenterology & Urology · 23d
Cleared Jul 23, 2021
Flex-Thread™ Distal Fibula lntramedullary Nail System
K212030 · HSB
Flower Orthopedics Corporation Dba...
Orthopedic · 24d
Cleared Jul 23, 2021
GI Genius
K211951 · QNP
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 30d
Cleared Jul 23, 2021
Klassic Knee System
K211602 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 60d
Cleared Jul 23, 2021
MySpine WebPlanner & MyBalance
K211386 · LLZ
Medacta International S.A.
Radiology · 79d
Cleared Jul 23, 2021
da Vinci SP Surgical System (SP1098)
K211316 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 84d
Cleared Jul 23, 2021
Altor Safety 3-Ply Surgical Mask (Model:62222)
K211249 · FXX
Altor Safety, LLC
General Hospital · 88d
Cleared Jul 23, 2021
Nitrile Patient Examination Gloves
K211012 · LZA
Huayuan Medical Technology(Shangqiu)...
General Hospital · 109d
Cleared Jul 23, 2021
IS Multi Unit Abutment System
K210903 · NHA
Neobiotech Co., Ltd.
Dental · 119d
Cleared Jul 23, 2021
SC1 Handheld Ultrasound Imaging System (Model: SC1)
K210468 · IYO
Fcu Co., Ltd.
Radiology · 157d
Cleared Jul 23, 2021
Blustone Synergy Diamond SA Cervical System
K210382 · OVE
Blustone Synergy, LLC
Orthopedic · 164d
Cleared Jul 23, 2021
Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B,...
K210311 · OHT
Shenzhen Mismon Technology Co., Ltd.
General & Plastic Surgery · 170d
Cleared Jul 23, 2021
CardioCurve Steerable Sheath
K210185 · DYB
Talon Surgical
Cardiovascular · 179d
Cleared Jul 23, 2021
IntraLock System
K210159 · HWC
Fusion Orthopedics, LLC
Orthopedic · 183d
Cleared Jul 23, 2021
Peregrine Endoscopy System
K202727 · EOB
3nt Medical , Ltd.
Ear, Nose, Throat · 309d
Cleared Jul 23, 2021
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or...
K202612 · JWY
Thermo Fisher Scientific
Microbiology · 317d
Cleared Jul 23, 2021
Infrared Forehead Thermometer, Model BSX976
K202296 · FLL
Shenzhen Bsx Technology Electronics...
General Hospital · 344d
Cleared Jul 23, 2021
Disposable IV catheter
K202060 · FOZ
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 361d
Cleared Jul 23, 2021
VS Newborn Heart Rate Monitor
K201887 · DQA
Surepulse Medical Limited
Cardiovascular · 380d
Cleared Jul 23, 2021
Disposable Microwave Therapeutic Antennas
K201265 · NEY
Nanjing Eco Microwave System Co., Ltd.
General & Plastic Surgery · 438d
Cleared Jul 23, 2021
HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
K201160 · ESW
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 449d
Cleared Jul 22, 2021
Reveal LINQ Insertable Cardiac Monitor
K212008 · MXD
Medtronic, Inc.
Cardiovascular · 24d
Cleared Jul 22, 2021
NIO+ Adult
K211968 · FMI
Waismed, Ltd.
General Hospital · 28d