Search FDA 510(k) Database

6,527 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: Cleared only ×
174,061 results
9553–9576 of 174,061
Cleared Mar 31, 2023
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
K230022 · FRN
Baxter Healthcare Corporation
General Hospital · 86d
Cleared Mar 31, 2023
IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32
K230021 · OHT
Shenzhen Yangyi Technology ., Ltd.
General & Plastic Surgery · 86d
Cleared Mar 31, 2023
Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K230003 · EIH
Topzir Biotech Co., Ltd.
Dental · 87d
Cleared Mar 31, 2023
Diode Laser Hair Removal System (RD-SLD600)
K223778 · GEX
Shanghai Omni Laser Skinology Co., Ltd.
General & Plastic Surgery · 105d
Cleared Mar 31, 2023
SonoAir Series Digital Color Doppler Ultrasound System
K223570 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 122d
Cleared Mar 31, 2023
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0
K223017 · IYN
Canon Medical Systems Corporation
Radiology · 183d
Cleared Mar 31, 2023
ROVO Mechanical Thrombectomy Device
K220780 · QEW
2mg, Inc.
Cardiovascular · 379d
Cleared Mar 31, 2023
Butterfly iQ/iQ+ Ultrasound System
K220068 · IYO
Butterfly Network, Inc.
Radiology · 445d
Cleared Mar 31, 2023
RadAlly
K213660 · LLZ
Imaging Wave, LLC
Radiology · 494d
Cleared Mar 31, 2023
Formus Hip
K213272 · QIH
Formus Labs, Ltd.
Radiology · 547d
Cleared Mar 31, 2023
CereFlow™ V1.2
K211059 · LLZ
Translational Mri, LLC
Radiology · 721d
Cleared Mar 30, 2023
Maestro Microcatheter
K230636 · KRA
Merit Medical System, Inc.
Cardiovascular · 23d
Cleared Mar 30, 2023
ARDO Bellis
K230590 · HGX
Ardo Medical AG
Obstetrics & Gynecology · 27d
Cleared Mar 30, 2023
Cemented Tibia Baseplate no Taper with JRNY Lock
K230555 · JWH
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Mar 30, 2023
ONLINE TDM Phenytoin - Free Phenytoin application
K230161 · MOJ
Roche Diagnostics
Chemistry · 69d
Cleared Mar 30, 2023
HOPKINS Telescopes
K223923 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 90d
Cleared Mar 30, 2023
Medartis APTUS® Ulna Plates
K223853 · HRS
Medartis AG
Orthopedic · 97d
Cleared Mar 30, 2023
Emory Cardiac Toolbox 4.3
K223422 · KPS
Syntermed
Radiology · 136d
Cleared Mar 30, 2023
BIASURGE Advanced Surgical Solution
K223377 · FRO
Rochal Technologies, LLC
General & Plastic Surgery · 146d
Cleared Mar 30, 2023
MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System,...
K223342 · HRS
Crossroads Extremity Systems, LLC
Orthopedic · 149d
Cleared Mar 30, 2023
Axiom PSR System
K223326 · OYK
Restor3d
Orthopedic · 150d
Cleared Mar 30, 2023
Comfort Marker 2.0
K222112 · QRN
Medical Precision BV
Radiology · 255d
Cleared Mar 30, 2023
ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
K221872 · MPA
Nova Eye Inc. (Business Name Nova Eye...
Ophthalmic · 275d
Cleared Mar 30, 2023
ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)
K221324 · OVD
Camber Spine Technologies
Orthopedic · 328d