Search FDA 510(k) Devices

5,460 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2022–2022 ×
3,212 results
1345–1368 of 3,212
Cleared Aug 09, 2022
NextGen Pedicle Screw System
K221776 · NKB
Corelink, LLC
Orthopedic · 49d
Cleared Aug 09, 2022
“POINT” Kinguide Robotic-Assisted Surgical System
K220241 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 193d
Cleared Aug 09, 2022
IMICRYL Composite, Composite Flow Materials
K220077 · EBF
Imicryl Dis Malzemeleri Sanayi VE...
Dental · 211d
Cleared Aug 09, 2022
NOVA RESIN dual cure, self adhesive resin cement
K213609 · EMA
Imicryl Dis Malzemeleri Sanayi VE...
Dental · 267d
Cleared Aug 09, 2022
Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue,...
K212482 · LYY
Sri Trang Gloves (Thailand) Public...
General Hospital · 365d
Cleared Aug 08, 2022
Dolphin Imaging 12.0
K222072 · LLZ
Patterson Dental Supply, Inc.
Radiology · 25d
Cleared Aug 08, 2022
Dental Impression Material
K221668 · ELW
Chemoment Materials Co.,Ltd
Dental · 61d
Cleared Aug 08, 2022
dS Sentinelle Breast 16ch 1.5T Coil
K213735 · MOS
Invivo Corporation (Business Trade...
Radiology · 252d
Cleared Aug 08, 2022
dS Sentinelle Breast 16ch 3.0T Coil
K213727 · MOS
Invivo Corporation (Business Trade...
Radiology · 255d
Cleared Aug 08, 2022
ClearPoint Maestro Brain Model
K213645 · QIH
ClearPoint Neuro, Inc.
Radiology · 263d
Cleared Aug 08, 2022
VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)
K212243 · LON
bioMerieux, Inc.
Microbiology · 385d
Cleared Aug 08, 2022
Dasky Disposable Sampling Tube (Model name: VSM02)
K211675 · QBD
Ningbo Dasky Life Science Co., Ltd.
Microbiology · 433d
Cleared Aug 06, 2022
Reprocesses Umbilical Cable
K221854 · NLH
Innovative Health, LLC
Cardiovascular · 40d
Cleared Aug 06, 2022
Pro Guard Nitrile Powder Free Examination Glove
K213934 · LZA
Medical Glove Co., Ltd.
General Hospital · 233d
Cleared Aug 05, 2022
Neurophet SCALE PET
K221405 · LLZ
Neurophet., Inc.
Radiology · 81d
Cleared Aug 05, 2022
Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with...
K221350 · LZA
Rubberex Alliance Products Sdn Bhd
General Hospital · 87d
Cleared Aug 05, 2022
Avéli
K221336 · OUP
Revelle Aesthetics, Inc.
General & Plastic Surgery · 88d
Cleared Aug 05, 2022
FAMA Male Latex Condoms
K220576 · HIS
Shanghai Personage Hygiene Products...
Obstetrics & Gynecology · 158d
Cleared Aug 05, 2022
TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
K220045 · LPL
Dk Medivision Co., Ltd.
Ophthalmic · 212d
Cleared Aug 05, 2022
Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
K213993 · LZA
Careglove Global Sdn. Bhd.
General Hospital · 227d
Cleared Aug 05, 2022
Spineology Navigation Instruments
K213876 · OLO
Spineology, Inc.
Orthopedic · 235d
Cleared Aug 05, 2022
Unispace SA Cervical Cage
K213791 · OVE
Edisoninno Co., Ltd.
Orthopedic · 242d
Cleared Aug 05, 2022
MONOFIX PGCL, knotless wound closure device
K212810 · GAM
Samyang Holdings Corp., Ltd.
General & Plastic Surgery · 336d
Cleared Aug 04, 2022
Masimo CARESCAPE SpO2 – Masimo with SpHb
K221953 · DQA
Masimo Corporation
Anesthesiology · 30d