Search FDA 510(k) Devices

5,353 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2024–2024 ×
3,129 results
73–96 of 3,129
Cleared Dec 20, 2024
HF-Etchant Hydrofluoric Acid Etching Gel
K242530 · KLE
Rizhao Huge Biomaterials Company, Ltd.
Dental · 116d
Cleared Dec 20, 2024
Tigon Medical All-Suture Anchors (ASA)
K242529 · MBI
Tigon Medical
Orthopedic · 116d
Cleared Dec 20, 2024
Lightning Viewer
K242362 · LLZ
Nexsys Electronics Inc. Dba Medweb
Radiology · 133d
Cleared Dec 20, 2024
Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620)
K242281 · FOZ
Arrow International, LLC (A...
General Hospital · 140d
Cleared Dec 20, 2024
Voluson Expert 18
K242168 · IYN
GE Medical Systems Ultrasound and...
Radiology · 149d
Cleared Dec 20, 2024
Single-use Balloon Dilatation Catheter
K241888 · FGE
Leo Medical Co., Ltd.
Gastroenterology & Urology · 175d
Cleared Dec 20, 2024
Momcozy Wearable Breast Pump (BP311)
K241680 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 192d
Cleared Dec 20, 2024
Fractional CO2 Laser Therapy System (FG900-S)
K241670 · GEX
Beijing Adss Development Co., Ltd.
General & Plastic Surgery · 192d
Cleared Dec 20, 2024
DASH® SARS-CoV-2 & Flu A/B Test
K241652 · QOF
Nuclein, LLC
Microbiology · 196d
Cleared Dec 20, 2024
Welch Allyn Connex® Spot Monitor
K241411 · MWI
Welch Allyn, Inc.
Cardiovascular · 217d
Cleared Dec 20, 2024
iHealth® Early Pregnancy Test
K241394 · LCX
Andon Health Co, Ltd.
Chemistry · 218d
Cleared Dec 20, 2024
BioSphere Putty
K241167 · MQV
Synergy Biomedical
Orthopedic · 238d
Cleared Dec 20, 2024
Alpha Dent Implants Dental Implants System
K240435 · DZE
Alpha Dent Implants GmbH
Dental · 310d
Cleared Dec 20, 2024
SmartClip Secure Soft Tissue Marker
K233639 · NEU
Elucent Medical, Inc.
General & Plastic Surgery · 403d
Cleared Dec 19, 2024
BD Vaginal Panel
K243725 · PQA
Becton, Dickinson and Company
Microbiology · 16d
Cleared Dec 19, 2024
Saige-Density (2.5.0)
K243705 · QIH
DeepHealth, Inc.
Radiology · 20d
Cleared Dec 19, 2024
Saige-Dx (3.1.0)
K243688 · QDQ
DeepHealth, Inc.
Radiology · 20d
Cleared Dec 19, 2024
Monoject™ Enteral Syringe with ENFit Connector (401SE)
K243652 · PNR
Cardinalhealth
Gastroenterology & Urology · 23d
Cleared Dec 19, 2024
OviTex PRS (Long-Term Resorbable)
K243595 · FTM
TELA Bio, Inc.
General & Plastic Surgery · 29d
Cleared Dec 19, 2024
Electric Wheelchair (HC820N)
K243440 · ITI
Yongkang Hengyi Vehicle Co., Ltd.
Physical Medicine · 43d
Cleared Dec 19, 2024
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
K243430 · NFO
Shenzhen Aozemei Technology Co., Ltd.
Neurology · 44d
Cleared Dec 19, 2024
Nutrifit
K243361 · FPD
Vygon USA
Gastroenterology & Urology · 51d
Cleared Dec 19, 2024
Yushan X-Ray Flat Panel Detector
K243171 · MQB
Innocare Optoelectronics Corp.
Radiology · 80d
Cleared Dec 19, 2024
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K243169 · JWY
Thermo Fisher Scientific
Microbiology · 80d