Search FDA 510(k) Database

6,781 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
13537–13560 of 174,061
Cleared Dec 23, 2021
Twist Drills
K213208 · HBE
Biomet Microfixation
Neurology · 85d
Cleared Dec 23, 2021
Vy Spine™ VyWasher™ Buttress System
K213219 · KWQ
Vy Spine, LLC
Orthopedic · 85d
Cleared Dec 23, 2021
D²RS and D²RS 9090
K213479 · OWB
Stephanix
Radiology · 55d
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
dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for...
K213766 · MOS
Invivo Corporation
Radiology · 22d
Cleared Dec 22, 2021
BoneMRI
K202404 · QIH
Mriguidance B.V.
Radiology · 488d
Cleared Dec 22, 2021
SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
K203564 · DJG
Immunalysis Corporation
Toxicology · 380d
Cleared Dec 22, 2021
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
K203647 · LAF
Immunalysis Corporation
Toxicology · 373d
Cleared Dec 22, 2021
Unico High Performance Surgical Mask, Unico High Performance Surgical Mask...
K210147 · FXX
Unicoglobal, Inc.
General Hospital · 335d
Cleared Dec 22, 2021
Pulse Oximeter
K210305 · DQA
Dongguan Lingxin Technologies Co., Ltd.
Anesthesiology · 322d
Cleared Dec 22, 2021
Neocis Guidance System (NGS) with Yomi Plan v2.0.1
K210711 · PLV
Neocis, Inc.
Dental · 287d
Cleared Dec 22, 2021
BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
K210978 · BSP
Becton, Dickinson and Company
Anesthesiology · 265d
Cleared Dec 22, 2021
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with...
K211022 · LZA
Central Medicare Sdn Bhd
General Hospital · 261d
Cleared Dec 22, 2021
Ultrast Gel
K211691 · MUI
Ultrast, Inc.
Radiology · 203d
Cleared Dec 22, 2021
Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310...
K212285 · NUH
Oriental Inspiration Limited
Neurology · 154d
Cleared Dec 22, 2021
EyeBOX (Model EBX-4)
K212310 · QEA
Oculogica, Inc.
Neurology · 152d
Cleared Dec 22, 2021
StealthStation S8 Cranial v2.0
K212397 · HAW
Medtronic Navigation
Neurology · 142d
Cleared Dec 22, 2021
Non Absorbable Surgical Nylon Suture
K212603 · GAR
Shandong Haidike Medical Product Co.,...
General & Plastic Surgery · 127d
Cleared Dec 22, 2021
SleepRight Select-Comfort Dental Guard
K212767 · MQC
Splintek, Inc.
Dental · 113d
Cleared Dec 22, 2021
Glovmaster Nitrile Examination Glove Powder Free
K212914 · LZA
Glovmaster Sdn. Bhd.
General Hospital · 100d
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
ID-500 iRestore Hair Growth System
K213094 · OAP
Freedom Laser Therapy, Inc.
General & Plastic Surgery · 89d
Cleared Dec 22, 2021
Claritas iPET
K213140 · LLZ
Claritas Healthtech Pte, Ltd.
Radiology · 86d
Cleared Dec 22, 2021
Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
K213144 · LYZ
Shen Wei (Usa), Inc.
General Hospital · 86d