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
1777–1800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 2025
Intri26 Introducer Sheath
K252508 · DYB
Inari Medical, Inc.
Cardiovascular · 131d
Cleared Dec 17, 2025
Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)
K252417 · DQY
Abbott Medical
Cardiovascular · 138d
Cleared Dec 17, 2025
SURFLO Hybria Closed System Safety IV Catheter
K252398 · FOZ
Terumo Medical Products Hangzhou Co.,...
General Hospital · 139d
Cleared Dec 17, 2025
BRUSIO Trauma Toolbox System
K252191 · HRS
Bonebridge AG
Orthopedic · 156d
Cleared Dec 17, 2025
UltraSight Guidance
K251416 · QJU
Ultrasight , Ltd.
Radiology · 224d
Cleared Dec 17, 2025
Multi-parameter Patient Monitor (N10)
K250854 · MHX
Shenzhen Comen Medical Instruments...
Cardiovascular · 271d
Cleared Dec 16, 2025
TroClose 1200
K253620 · GAM
Gordian Surgical, Ltd.
General & Plastic Surgery · 28d
Cleared Dec 16, 2025
Companion Spine DIAM™ Instrumentation
K253118 · QLR
Companion Spine France
Orthopedic · 83d
Cleared Dec 16, 2025
VR® Personal Protective Level 3 Gown (VR Gowns)
K252940 · QPC
PolyConversions, Inc.
General Hospital · 92d
Cleared Dec 16, 2025
IDENTIFY (5.0)
K252919 · IYE
Varian Medical Systems, Inc.
Radiology · 95d
Cleared Dec 16, 2025
Single-use Digital Flexible Ureteroscope (GY-UR9.3)
K252468 · FGB
Zhejiang Geyi Medical Instrument Co.,...
Gastroenterology & Urology · 132d
Cleared Dec 16, 2025
BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology
K252373 · LJS
Spectrum Vascular
General Hospital · 139d
Cleared Dec 16, 2025
V series portable oxygen concentrator (V5, V5C, V6, V6C)
K252268 · CAW
Shenzhen Harveymed Technology Co., Ltd.
Anesthesiology · 148d
Cleared Dec 16, 2025
prolaio eVO2peak Module (Version 1.0)
K252204 · PPW
Prolaio, Inc.
Cardiovascular · 155d
Cleared Dec 16, 2025
Versius Surgical System (Versius Plus)
K252111 · SCV
Cmr Surgical Limited
General & Plastic Surgery · 162d
Cleared Dec 16, 2025
Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3,...
K251951 · FGB
Guangzhou Red Pine Medical Instrument...
Gastroenterology & Urology · 174d
Cleared Dec 16, 2025
SKAN C PULSAR
K251893 · OWB
Skanray Technologies Limited
Radiology · 179d
Cleared Dec 16, 2025
Cambridge Partial Knee
K251771 · HSX
Signature Orthopaedics Pty, Ltd.
Orthopedic · 189d
Cleared Dec 16, 2025
IRISeg
K251763 · QIH
Intuitive Surgical, Inc.
Radiology · 190d
Cleared Dec 16, 2025
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
K251745 · DXQ
Baxter Healthcare Corporation
Cardiovascular · 193d
Cleared Dec 16, 2025
PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family)
K251256 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 237d
Cleared Dec 16, 2025
ADVIA Centaur Cytokeratin Fragment 21-1
K250925 · OVK
Fujirebio Diagnostics,Inc.
Immunology · 264d
Cleared Dec 15, 2025
V•Stick™ Vascular Access Set
K253741 · DYB
Argon Medical Devices, Inc.
Cardiovascular · 21d
Cleared Dec 15, 2025
Tembo Embolic System
K253677 · KRD
Instylla, Inc.
Cardiovascular · 24d