FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
10705–10728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 2023
Ballancer Platinum (1222)
K230385 · IRP
Mego Afek
Physical Medicine · 49d
Cleared Apr 03, 2023
G7, Dental Operative Unit and Accessories
K213749 · EIA
Shinhung Company, Ltd.
Dental · 489d
Cleared Apr 03, 2023
Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile...
K220454 · NAM
Avation Medical, Inc.
Gastroenterology & Urology · 410d
Cleared Apr 03, 2023
iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
K221802 · QBD
Mawi Dna Technologies
Microbiology · 286d
Cleared Apr 03, 2023
Sclerotherapy & Endoscopic Needles
K222006 · FBK
G-Flex Europe Sprl
Gastroenterology & Urology · 270d
Cleared Apr 03, 2023
M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore...
K222865 · KNW
Canyon Medical, Inc.
General & Plastic Surgery · 193d
Cleared Apr 03, 2023
Annalise Enterprise CTB Triage Trauma
K223240 · QAS
Annalise-Ai Pty , Ltd.
Radiology · 165d
Cleared Apr 03, 2023
Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall...
K230028 · JOW
Cardinal Health200, LLC
Cardiovascular · 89d
Cleared Apr 02, 2023
SpO2 Extension Cable
K222370 · DSA
Beijing Rongrui-Century Science &...
Anesthesiology · 240d
Cleared Apr 01, 2023
Maxtec MaxO2 ME+p
K221734 · CCL
Maxtec, LLC
Anesthesiology · 290d
Cleared Apr 01, 2023
FiberTak Suture Anchor
K230568 · MBI
Arthrex, Inc.
Orthopedic · 31d
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