Search FDA 510(k) Database

6,727 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
12601–12624 of 174,061
Cleared Apr 22, 2022
PicoStar
K213889 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 130d
Cleared Apr 22, 2022
HealthOST
K213944 · JAK
Nanoxai , Ltd.
Radiology · 126d
Cleared Apr 22, 2022
HYBRID S70
K220574 · EHD
Digimed Co., Ltd.
Radiology · 53d
Cleared Apr 22, 2022
Avanos* CORTRAK* 2 Enteral Access System (EAS)
K220588 · KNT
Avanos Medical, Inc.
Gastroenterology & Urology · 52d
Cleared Apr 22, 2022
1 Series Phototherapy Equipment
K220840 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 30d
Cleared Apr 22, 2022
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688...
K220895 · GCJ
Stryker
General & Plastic Surgery · 25d
Cleared Apr 21, 2022
Waterlase iPLus
K210183 · GEX
Biolase, Inc.
General & Plastic Surgery · 451d
Cleared Apr 21, 2022
HydroMARK Breast Biopsy Site Marker
K212158 · NEU
Devicor Medical Products, Inc.
General & Plastic Surgery · 283d
Cleared Apr 21, 2022
Tempo Tampon
K212277 · HEB
Dong-A Pharmaceutical Co., Ltd.
Obstetrics & Gynecology · 275d
Cleared Apr 21, 2022
INHANCE™ Reverse Shoulder System
K212737 · PHX
Depuy Ireland UC
Orthopedic · 234d
Cleared Apr 21, 2022
GEMS-H
K213452 · PHL
Samsung Electronics Co., Ltd.
Neurology · 177d
Cleared Apr 21, 2022
FEMTO LDV Z8 Femtosecond Surgical Laser
K213559 · OOE
Sie Ag,Surgical Instrument Engineering
Ophthalmic · 168d
Cleared Apr 21, 2022
Ivory Glove Powder-Free Nitrile Examination Gloves
K213681 · LZA
Ivory Gloves Sdn. Bhd.
General Hospital · 150d
Cleared Apr 21, 2022
MESI mTABLET TBI diagnostic system, MESI mTABLET TBI
K213730 · JOM
Mesi, Development of Medical Devices,...
Cardiovascular · 146d
Cleared Apr 21, 2022
Videa Caries Assist
K213795 · MYN
Videahealth, Inc.
Radiology · 136d
Cleared Apr 21, 2022
GM85
K220175 · IZL
Samsung Electronics Co., Ltd.
Radiology · 90d
Cleared Apr 21, 2022
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy...
K220382 · LZA
Jiangsu Bytech Medical Supplies Co.,...
General Hospital · 70d
Cleared Apr 21, 2022
Venus Bulk Flow ONE
K220605 · EBF
Kulzer, LLC
Dental · 50d
Cleared Apr 20, 2022
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
K212022 · QKM
3M Company
General Hospital · 295d
Cleared Apr 20, 2022
SmoothCool HR System
K213484 · GEX
Jeisys Medical, Inc.
General & Plastic Surgery · 173d
Cleared Apr 20, 2022
GEM FLOW COUPLER Monitor (GEM1020M-2)
K213974 · DPW
Synovis Micro Companies Alliance, Inc.
General & Plastic Surgery · 121d
Cleared Apr 20, 2022
Auxo A300, A150 and APod
K220543 · OAP
Auxo Hair, LLC
General & Plastic Surgery · 54d
Cleared Apr 20, 2022
EKOS+ Endovascular Device
K220866 · QEY
Boston Scientific
Cardiovascular · 26d
Cleared Apr 20, 2022
Saberscope5 Laparoscope
K220872 · GCJ
Xenocor, Inc.
General & Plastic Surgery · 26d