FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
10441–10464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 2023
CereFlow™ V1.2
K211059 · LLZ
Translational Mri, LLC
Radiology · 721d
Cleared Mar 31, 2023
Formus Hip
K213272 · QIH
Formus Labs, Ltd.
Radiology · 547d
Cleared Mar 31, 2023
RadAlly
K213660 · LLZ
Imaging Wave, LLC
Radiology · 494d
Cleared Mar 31, 2023
Butterfly iQ/iQ+ Ultrasound System
K220068 · IYO
Butterfly Network, Inc.
Radiology · 445d
Cleared Mar 31, 2023
ROVO Mechanical Thrombectomy Device
K220780 · QEW
2mg, Inc.
Cardiovascular · 379d
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
SonoAir Series Digital Color Doppler Ultrasound System
K223570 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 122d
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
Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K230003 · EIH
Topzir Biotech Co., Ltd.
Dental · 87d
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
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
K230022 · FRN
Baxter Healthcare Corporation
General Hospital · 86d
Cleared Mar 31, 2023
Spectrum IQ Infusion System with Dose IQ Safety Software
K230041 · FRN
Baxter Healthcare Corporation
General Hospital · 84d
Cleared Mar 31, 2023
BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug...
K230238 · DJG
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 60d
Cleared Mar 31, 2023
Medical Diode Laser (M2)
K230274 · GEX
Wuhan Pioon Technology Co., Ltd.
General & Plastic Surgery · 58d
Cleared Mar 31, 2023
Iris AirShuttle™
K230312 · IYE
Qfix
Radiology · 56d
Cleared Mar 31, 2023
Aspirex™ Thrombectomy System
K230356 · QEW
C.R. Bard, Inc.
Cardiovascular · 50d
Cleared Mar 31, 2023
1788 4K Camera System with Advanced Imaging Modality
K230605 · GCJ
Stryker
General & Plastic Surgery · 28d
Cleared Mar 30, 2023
Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with...
K220088 · LZA
Professional Latex Sdn Bhd
General Hospital · 443d
Cleared Mar 30, 2023
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing...
K221320 · OBO
Nidek Co., Ltd.
Ophthalmic · 328d
Cleared Mar 30, 2023
ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)
K221324 · OVD
Camber Spine Technologies
Orthopedic · 328d
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
Comfort Marker 2.0
K222112 · QRN
Medical Precision BV
Radiology · 255d
Cleared Mar 30, 2023
Axiom PSR System
K223326 · OYK
Restor3d
Orthopedic · 150d
Cleared Mar 30, 2023
MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System,...
K223342 · HRS
Crossroads Extremity Systems, LLC
Orthopedic · 149d