Search FDA 510(k) Devices

5,377 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2021–2021 ×
3,023 results
457–480 of 3,023
Cleared Nov 12, 2021
Intellijoint VIEW
K211876 · LLZ
Intellijoint Surgical, Inc.
Radiology · 148d
Cleared Nov 12, 2021
Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™...
K211359 · PHX
Tornier, Inc.
Orthopedic · 193d
Cleared Nov 12, 2021
Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial,...
K210989 · HAW
Brainlab AG
Neurology · 224d
Cleared Nov 12, 2021
ETEST Fosfomycin (FO) (0.032-512 µg/mL)
K210757 · JWY
Biomerieux S.A.
Microbiology · 242d
Cleared Nov 12, 2021
Wrap Accessory Electrodes
K210383 · GXY
Hi-Dow International, Inc.
Physical Medicine · 276d
Cleared Nov 12, 2021
HYDRASHIFT 2/4 isatuximab
K203184 · CFF
Sebia
Immunology · 381d
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
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
K202319 · FMI
Tianjin Huahong Technology Co., Ltd.
General Hospital · 452d
Cleared Nov 11, 2021
EnSite X EP System
K213364 · DQK
Abbott Medical
Cardiovascular · 30d
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
Nitrile Examination Glove (Powder free, Blue)
K212497 · LZA
Jiangsu Jinlian Medical Technology...
General Hospital · 94d
Cleared Nov 10, 2021
Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity...
K213389 · JWH
Conformis, Inc.
Orthopedic · 26d
Cleared Nov 10, 2021
Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector
K213089 · FPA
Ivenix, Inc.
General Hospital · 47d
Cleared Nov 10, 2021
Diode laser therapy system
K212978 · GEX
Beijing Unt Technology Co., Ltd.
General & Plastic Surgery · 54d
Cleared Nov 10, 2021
RTapp
K212887 · LLZ
Segana, Inc.
Radiology · 61d
Cleared Nov 10, 2021
More-Cell-System
K212659 · PMU
Agency For Medical Innovations GmbH
Obstetrics & Gynecology · 79d
Cleared Nov 10, 2021
AlignRT Plus
K212583 · IYE
Vision Rt, Ltd.
Radiology · 86d
Cleared Nov 10, 2021
Disposable Automatic Core Biopsy Instrument
K212284 · KNW
Suzhou Leapmed Healthcare Corporation
Gastroenterology & Urology · 112d
Cleared Nov 10, 2021
Reverso
K212107 · GEI
Intelis Instruments , Ltd.
General & Plastic Surgery · 127d
Cleared Nov 10, 2021
eKuore Pro 4T - REF EP0098
K212013 · DQD
Chip Ideas Electronics S.L.
Cardiovascular · 135d
Cleared Nov 10, 2021
ESSENZ Patient Monitor
K212003 · DXJ
Livanova Deutschland, GmbH
Cardiovascular · 135d
Cleared Nov 10, 2021
Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7...
K211975 · OTN
Caldera Medical, Inc.
Gastroenterology & Urology · 138d
Cleared Nov 10, 2021
Lunit INSIGHT CXR Triage
K211733 · QFM
Lunit, Inc.
Radiology · 159d
Cleared Nov 10, 2021
VSP® Orthopedics System
K211244 · PBF
3D Systems
Orthopedic · 198d