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
6889–6912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 2024
SIGNEX
K230546 · HRS
Osteonic Co., Ltd.
Orthopedic · 469d
Cleared Jun 11, 2024
InActiv Blue
K221547 · QBD
Fertipro NV
Microbiology · 746d
Cleared Jun 10, 2024
Indigo® Lightning Flash Aspiration System – Select +™ Catheter
K241399 · QEW
Penumbra, Inc.
Cardiovascular · 25d
Cleared Jun 10, 2024
Medical Diode Laser (S1Pro)
K240644 · GEX
Wuhan Pioon Technology Co., Ltd.
General & Plastic Surgery · 95d
Cleared Jun 10, 2024
BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB,...
K240283 · FAJ
MacroLux Medical Technology Co., Ltd.
Gastroenterology & Urology · 130d
Cleared Jun 10, 2024
Venue Sprint
K240206 · IYN
GE Medical Systems Ultrasound and...
Radiology · 137d
Cleared Jun 10, 2024
Venue
K240111 · IYN
GE Medical Systems Ultrasound and...
Radiology · 146d
Cleared Jun 10, 2024
Wrap Accessory Electrodes (GMX-ABSBELT01
K240108 · GXY
Gymmax Technology Shenzhen Co., Ltd.
Physical Medicine · 146d
Cleared Jun 10, 2024
Histofreezer V
K240106 · GEH
Cryoconcepts LP
General & Plastic Surgery · 146d
Cleared Jun 10, 2024
Venue Go
K240053 · IYN
GE Medical Systems Ultrasound and...
Radiology · 154d
Cleared Jun 10, 2024
Venue Fit
K234106 · IYN
GE Medical Systems Ultrasound and...
Radiology · 167d
Cleared Jun 10, 2024
OmniTom Elite
K233767 · JAK
Neurologica Corporation
Radiology · 199d
Cleared Jun 10, 2024
KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection]...
K232911 · FGB
Karl Storz Endovision, Inc.
Gastroenterology & Urology · 265d
Cleared Jun 07, 2024
Access Thyroglobulin
K241423 · MSW
Beckman Coulter, Inc.
Immunology · 18d
Cleared Jun 07, 2024
iLoop Interventional Coil 0.55T
K241069 · MOS
Noras Mri Products GmbH
Radiology · 49d
Cleared Jun 07, 2024
Cardiac CT Function Software Application
K241038 · QIH
Circle Cardiovascular Imaging
Radiology · 52d
Cleared Jun 07, 2024
Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)
K240972 · NLH
Surgical Instrument Service and...
Cardiovascular · 59d
Cleared Jun 07, 2024
Blood Pressure Monitor (BBZ32-AA01)
K240832 · DXN
Guangdong Transtek Medical...
Cardiovascular · 73d
Cleared Jun 07, 2024
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST,...
K240672 · EIH
Zhejiang Zahndent Biotechnology Co.,...
Dental · 88d
Cleared Jun 07, 2024
IPD Dental Implant Abutments
K240570 · NHA
Implant Protesis Dental 2004, S.L.
Dental · 99d
Cleared Jun 07, 2024
Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant
K234099 · NUC
Select Labs, LLC
Obstetrics & Gynecology · 164d
Cleared Jun 07, 2024
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
K234042 · QIH
Ever Fortune.Ai, Co., Ltd.
Radiology · 169d
Cleared Jun 07, 2024
Libre Rio Continuous Glucose Monitoring System
K233861 · SBH
Abbott Diabetes Care
Chemistry · 184d
Cleared Jun 07, 2024
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
K233825 · NLH
Innovative Health
Cardiovascular · 189d