Search FDA 510(k) Devices

5,352 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2021–2021 ×
3,023 results
25–48 of 3,023
Cleared Dec 24, 2021
Skypro, SP02 Mask (3)
K202255 · FXX
Skypro Medical Supplies Company
General Hospital · 501d
Cleared Dec 23, 2021
dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for...
K213766 · MOS
Invivo Corporation
Radiology · 22d
Cleared Dec 23, 2021
SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE...
K213547 · HIS
Ttk Healthcare Limited
Obstetrics & Gynecology · 45d
Cleared Dec 23, 2021
D²RS and D²RS 9090
K213479 · OWB
Stephanix
Radiology · 55d
Cleared Dec 23, 2021
Vy Spine™ VyWasher™ Buttress System
K213219 · KWQ
Vy Spine, LLC
Orthopedic · 85d
Cleared Dec 23, 2021
Twist Drills
K213208 · HBE
Biomet Microfixation
Neurology · 85d
Cleared Dec 23, 2021
NBR Synthetic Nitrile Examination Gloves
K212436 · LYZ
Shandong Langtai International Trade...
General Hospital · 141d
Cleared Dec 23, 2021
Integrity Implants Navigated Instruments
K212088 · OLO
Integrity Implants, Inc.
Orthopedic · 170d
Cleared Dec 23, 2021
Altech® Exhalation Valve (Single Limb and Dual Limb)
K210992 · CBP
Meditera Tibbi Malzeme San VE Tic AS
Anesthesiology · 265d
Cleared Dec 23, 2021
Curian Campy
K210976 · LQP
Meridian Bioscience, Inc.
Microbiology · 266d
Cleared Dec 23, 2021
NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar...
K203714 · MAX
Nu Vasive, Incorporated
Orthopedic · 367d
Cleared Dec 23, 2021
Sonomed IV, Sonomed V
K202788 · IMI
Carci Industria E Comercio DE...
Physical Medicine · 457d
Cleared Dec 23, 2021
Contour® next GEN Blood Glucose Monitoring System
K193407 · NBW
Ascensia Diabetes Care
Chemistry · 745d
Cleared Dec 22, 2021
Solas OR
K213691 · MWP
Cirdan Imaging, Ltd.
Radiology · 29d
Cleared Dec 22, 2021
EdgePro
K213428 · NVK
Biolase, Inc.
Dental · 62d
Cleared Dec 22, 2021
iSR’obot Mona Lisa 2.0
K213411 · IYO
Biobot Surgical Pte., Ltd.
Radiology · 64d
Cleared Dec 22, 2021
Diode Laser System GP900A8, Diode Laser System GP900Q8
K213225 · GEX
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 84d
Cleared Dec 22, 2021
Sheath, Stopcock Accessory
K213207 · HIH
Olympus Winter & Ibe GmbH
Obstetrics & Gynecology · 84d
Cleared Dec 22, 2021
Encore System
K213159 · ORY
Siesta Medical, Inc.
Dental · 85d
Cleared Dec 22, 2021
Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
K213144 · LYZ
Shen Wei (Usa), Inc.
General Hospital · 86d
Cleared Dec 22, 2021
Claritas iPET
K213140 · LLZ
Claritas Healthtech Pte, Ltd.
Radiology · 86d
Cleared Dec 22, 2021
ID-500 iRestore Hair Growth System
K213094 · OAP
Freedom Laser Therapy, Inc.
General & Plastic Surgery · 89d
Cleared Dec 22, 2021
Oren LED Perioral Light Therapy System
K213024 · OHS
Shenzhen Kaiyan Medical CO , Ltd.
General & Plastic Surgery · 92d
Cleared Dec 22, 2021
Glovmaster Nitrile Examination Glove Powder Free
K212914 · LZA
Glovmaster Sdn. Bhd.
General Hospital · 100d