Search FDA 510(k) Devices

5,378 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2024–2024 ×
3,129 results
457–480 of 3,129
Cleared Nov 13, 2024
RESPOND(R) Ventilator
K241135 · CBK
Corvent Medical, Inc.
Anesthesiology · 203d
Cleared Nov 13, 2024
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW,...
K240337 · EFB
Guangdong Jinme Medical Technology...
Dental · 282d
Cleared Nov 13, 2024
Nonin OTC Pulse Oximeter Model 3250
K211498 · OLK
Nonin Medical, Inc.
Anesthesiology · 1279d
Not Cleared Nov 13, 2024
SmartFlow Neuro Cannula
DEN240023 · SDG
ClearPoint Neuro, Inc.
Neurology · 175d
Cleared Nov 12, 2024
Electric wheelchair (KR-8807)
K242791 · ITI
Zhejiang Kairui Medical Device Co., Ltd.
Physical Medicine · 57d
Cleared Nov 12, 2024
InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
K242775 · NDC
Medtronic Minimed
Chemistry · 60d
Cleared Nov 12, 2024
Aurelia Surgical Mask ASTM Level-3 (2130)
K242502 · FXX
Supermax Healthcare Canada-Supermax...
General Hospital · 82d
Cleared Nov 12, 2024
Power-Flex (PFX1214)
K242430 · ITI
Soul Mobility
Physical Medicine · 89d
Cleared Nov 12, 2024
pNOVUS 21 Microcatheter
K242420 · DQO
Phenox, Ltd.
Neurology · 89d
Cleared Nov 12, 2024
Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10,...
K242173 · FED
Coloplast Corp.
Gastroenterology & Urology · 111d
Cleared Nov 12, 2024
UbiqVue™ 2A Multi-parameter System (UX2550)
K242018 · DRG
Lifesignals, Inc.
Cardiovascular · 125d
Cleared Nov 12, 2024
Change Healthcare Stratus Imaging PACS
K241981 · LLZ
Change Healthcare Canada Company
Radiology · 130d
Cleared Nov 12, 2024
High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22),...
K241074 · EFB
Foshan Soco Precision Instrument Co.,...
Dental · 207d
Cleared Nov 12, 2024
PRORAD X-Ray Flat Panel Detector with DROC
K240771 · MQB
Prognosys Medical Systems Private...
Radiology · 236d
Cleared Nov 12, 2024
AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask
K230915 · CCK
Vyaire Medical, Inc.
Anesthesiology · 592d
Not Cleared Nov 12, 2024
VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator
DEN230085 · SDC
Steris
General Hospital · 330d
Cleared Nov 11, 2024
Straumann® Anatomic Healing Abutments XC (AHA)
K241575 · NHA
Straumann USA, LLC
Dental · 161d
Cleared Nov 09, 2024
esolution® Esophageal Retractor
K243233 · QXU
S4 Medical Corp.
Cardiovascular · 31d
Cleared Nov 08, 2024
Trigon PEEK HA Wedges
K243231 · PLF
Nvision Biomedical Technologies
Orthopedic · 30d
Cleared Nov 08, 2024
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323,...
K243075 · ODC
STERIS Corporation
Gastroenterology & Urology · 42d
Cleared Nov 08, 2024
Xpine Spinal Fixation System
K243004 · NKB
Jeil Medical Corporation
Orthopedic · 43d
Cleared Nov 08, 2024
CLUNGENE Fentanyl Home Test Cassette
K242802 · NGL
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 52d
Cleared Nov 08, 2024
Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080,...
K242756 · DYB
Pulnovo Medical (Wuxi) Co., Ltd.
Cardiovascular · 57d
Cleared Nov 08, 2024
TopCEM Ceramic Primer Ceramic Coupling Agent
K242749 · KLE
Rizhao Huge Biomaterials Company, Ltd.
Dental · 57d