Search FDA 510(k) Devices

5,404 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2021–2021 ×
3,023 results
937–960 of 3,023
Cleared Sep 16, 2021
6430 MyLabX75, 6430 MyLab XPro75
K212021 · IYN
Esaote, S.P.A.
Radiology · 80d
Cleared Sep 16, 2021
VISIONAIRE UK Patient Matched Cutting Guides
K211512 · HSX
Smith & Nephew, Inc.
Orthopedic · 125d
Cleared Sep 16, 2021
Blue Nitrile Examination Glove Powder Free
K211479 · LZA
Aspen Glove Sdn. Bhd.
General Hospital · 127d
Cleared Sep 16, 2021
Sterile Latex Surgical Gloves Powder Free
K211478 · KGO
Aspen Glove Sdn. Bhd.
General Hospital · 127d
Cleared Sep 16, 2021
Disposable Medical Mask
K203112 · FXX
Yangzhou Runyi Arts & Crafts Co., Ltd.
General Hospital · 336d
Cleared Sep 16, 2021
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
K203111 · DTZ
Medtronic
Cardiovascular · 336d
Cleared Sep 15, 2021
GLOBAL UNITE™ Platform Shoulder System
K212710 · PHX
Depuy Ireland UC
Orthopedic · 20d
Cleared Sep 15, 2021
BeamSite
K212606 · IYE
Doseoptics, LLC
Radiology · 29d
Cleared Sep 15, 2021
mi-eye 3 needlescope with cannula, mi-tablet 3
K212556 · HRX
Trice Medical, Inc.
Orthopedic · 33d
Cleared Sep 15, 2021
Disposable Nitrile Gloves
K212009 · LZA
Jiangsu Shenglijie Safety Products...
General Hospital · 79d
Cleared Sep 15, 2021
Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters
K211276 · NLH
Innovative Health, LLC
Cardiovascular · 141d
Cleared Sep 15, 2021
HTx Disposable Hysteroscope System
K211227 · HIH
Acuvu, Inc.
Obstetrics & Gynecology · 145d
Cleared Sep 15, 2021
TrueCare Biomedix Tamper Evident Cap
K210818 · FMF
Us Infusion Inc. D/B/A Truecare...
General Hospital · 181d
Cleared Sep 15, 2021
INFRARED BODY THERMOMETER (Model: YK-001)
K210118 · FLL
Longnan Renzhong Medical Equipment...
General Hospital · 239d
Cleared Sep 15, 2021
HealthCCSng
K210085 · JAK
Zebra Medical Vision, Ltd.
Radiology · 245d
Cleared Sep 15, 2021
TruAbutment DS, TruBase
K203649 · NHA
Truabutment, Inc.
Dental · 275d
Cleared Sep 15, 2021
Instrument tray, for semi-rigid ureteroscope
K203492 · KCT
Olympus Winter & Ibe GmbH
General Hospital · 300d
Cleared Sep 15, 2021
GlucoSure HT Plus Blood Glucose Monitoring System
K202885 · NBW
Apex BioTechnology Corp.
Chemistry · 352d
Cleared Sep 15, 2021
RXS 1000
K202369 · MUH
Rolence Enterprise, Inc.
Radiology · 392d
Cleared Sep 14, 2021
Viveve System, Viveve 2.0 System
K212678 · GEI
Viveve Medical, Inc.
General & Plastic Surgery · 21d
Cleared Sep 14, 2021
PHOENIX
K212291 · IZL
Sedecal., Sa.
Radiology · 54d
Cleared Sep 14, 2021
Rotarex Atherectomy System
K211738 · MCW
C.R. Bard, Inc.
Cardiovascular · 99d
Cleared Sep 14, 2021
Polaris X Unidirectional Steerable Diagnostic Catheter
K211494 · DRF
Boston Scientific Corporation
Cardiovascular · 124d
Cleared Sep 14, 2021
Kleiner KG2 System
K211474 · MAX
BAAT Medical Products B.V.
Orthopedic · 125d