Search FDA 510(k) Database

6,797 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
13945–13968 of 174,061
Cleared Nov 15, 2021
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
K213497 · MQB
H&abyz Co., Ltd.
Radiology · 14d
Cleared Nov 14, 2021
Spin Care Disposable Protective Mask Level 3
K212109 · FXX
Spintech, LLC
General Hospital · 131d
Cleared Nov 14, 2021
Surgical Face Mask
K212575 · FXX
Hubei Huanfu Plastic Products Co., Ltd.
General Hospital · 90d
Cleared Nov 13, 2021
Disposable Surgical Gowns
K210785 · FYC
Chongqing Litai Fashion Group Limited...
General Hospital · 242d
Cleared Nov 13, 2021
Surgical Face mask
K212264 · FXX
Nantong Taiweishi Medical Technology...
General Hospital · 116d
Cleared Nov 12, 2021
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
K202319 · FMI
Tianjin Huahong Technology Co., Ltd.
General Hospital · 452d
Cleared Nov 12, 2021
DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)
K202671 · NUH
Guangzhou Xinbo Electronic Co., Ltd.
Physical Medicine · 424d
Cleared Nov 12, 2021
HYDRASHIFT 2/4 isatuximab
K203184 · CFF
Sebia
Immunology · 381d
Cleared Nov 12, 2021
Wrap Accessory Electrodes
K210383 · GXY
Hi-Dow International, Inc.
Physical Medicine · 276d
Cleared Nov 12, 2021
ETEST Fosfomycin (FO) (0.032-512 µg/mL)
K210757 · JWY
Biomerieux S.A.
Microbiology · 242d
Cleared Nov 12, 2021
Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial,...
K210989 · HAW
Brainlab AG
Neurology · 224d
Cleared Nov 12, 2021
Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™...
K211359 · PHX
Tornier, Inc.
Orthopedic · 193d
Cleared Nov 12, 2021
Intellijoint VIEW
K211876 · LLZ
Intellijoint Surgical, Inc.
Radiology · 148d
Cleared Nov 12, 2021
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K212259 · EIH
Zirdent New Material Co., Ltd.
Dental · 115d
Cleared Nov 12, 2021
NightGuard Flex
K212448 · MQC
Sprintray, Inc.
Dental · 99d
Cleared Nov 12, 2021
Erchonia FX-405
K212595 · NHN
Erchonia Corporation
Physical Medicine · 88d
Cleared Nov 12, 2021
MAMMOVISTA B.smart
K212621 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 86d
Cleared Nov 12, 2021
MiPACS HTML5 Web Viewer
K212984 · LLZ
Lead Technologies, Inc.
Radiology · 56d
Cleared Nov 11, 2021
Nitrile Examination Glove (Powder free, Blue)
K212497 · LZA
Jiangsu Jinlian Medical Technology...
General Hospital · 94d
Cleared Nov 11, 2021
Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy...
K212532 · LZA
Crdlight Optoelectronic Technology...
General Hospital · 92d
Cleared Nov 11, 2021
EnSite X EP System
K213364 · DQK
Abbott Medical
Cardiovascular · 30d
Cleared Nov 10, 2021
LTV2 Series Ventilators
K201082 · CBK
Vyaire Medical, Inc.
Anesthesiology · 566d
Cleared Nov 10, 2021
Venen-trainer (Model: FM150, SFM90)
K203746 · JOW
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 323d
Cleared Nov 10, 2021
inVisionOS
K210344 · LLZ
Precisionos Technology, Inc.
Radiology · 278d