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
2689–2712 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 2025
G aenial Universal Injectable II
K251946 · EBF
GC America, Inc.
Dental · 65d
Cleared Aug 29, 2025
EZ™ IV Administration Set
K251814 · FPA
Epic Medical Pte. , Ltd.
General Hospital · 77d
Cleared Aug 29, 2025
GLAM LED Facial Mask (TB-2386F)
K251727 · GEX
Touchbeauty Beauty & Health...
General & Plastic Surgery · 85d
Cleared Aug 29, 2025
ArTT Augments and Buttresses and Bone Screws
K251718 · LPH
Lima Corporate S.P.A.
Orthopedic · 86d
Cleared Aug 29, 2025
PV01 PVDF Effort Sensor
K251480 · SFK
Neurotronics, LLC
Anesthesiology · 108d
Cleared Aug 29, 2025
da Vinci SP Surgical System (SP1098)
K251324 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 122d
Cleared Aug 29, 2025
SmartGuard technology
K251217 · QJI
Medtronic Minimed, Inc.
Chemistry · 130d
Cleared Aug 29, 2025
Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5)
K251181 · DQX
Merit Medical Ireland, Ltd.
Cardiovascular · 135d
Cleared Aug 29, 2025
Erbe ESU Model VIO® 3n with Accessories
K251108 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 140d
Cleared Aug 29, 2025
Sonosite LX and Sonosite PX Ultrasound Systems
K251106 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 140d
Cleared Aug 29, 2025
Regenesis EMS Chair
K251026 · KPI
Trinity Medical Solutions
Gastroenterology & Urology · 149d
Cleared Aug 29, 2025
SIRIUS Endoscope System (PR-SI-1230)
K250939 · HET
Precision Robotics (Hong Kong) Limited
General & Plastic Surgery · 154d
Cleared Aug 29, 2025
Sunrise
K250874 · QRS
Sunrise SA
Anesthesiology · 158d
Cleared Aug 29, 2025
Primescan 2
K250771 · NTK
Dentsply Sirona, Inc.
Dental · 169d
Cleared Aug 29, 2025
IVA & AEON Cervical and Lumbar Cage System
K250335 · ODP
K&J Consulting
Orthopedic · 205d
Cleared Aug 29, 2025
SurgiTwin
K250290 · LLZ
Twinsight
Radiology · 210d
Cleared Aug 29, 2025
NEUROVENT-P (092946-003)
K250285 · GWM
Raumedic AG
Neurology · 210d
Cleared Aug 29, 2025
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
K250003 · PZM
Geneseeq Technology, Inc.
Pathology · 239d
Cleared Aug 29, 2025
PRAEVAorta®2
K243859 · QIH
Nurea
Radiology · 256d
Cleared Aug 29, 2025
Fetal Pillow
K243799 · PWB
CooperSurgical, Inc.
Obstetrics & Gynecology · 261d
Cleared Aug 29, 2025
FG Bone Graft B
K243745 · LYC
Full Golden Biotech Corporation
Dental · 267d
Cleared Aug 28, 2025
Powder-Free Vinyl Exam Gloves, clear
K252505 · LYZ
Basic Medical Technology, Inc.
General Hospital · 20d
Cleared Aug 28, 2025
JAZZ Spinal System
K252437 · NKB
Implanet
Orthopedic · 27d
Cleared Aug 28, 2025
JARVIS Glenoid Reverse Shoulder Prosthesis
K252411 · PHX
FH Industrie
Orthopedic · 27d