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
2161–2184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 2025
Seguin Annuloplasty Ring
K253232 · KRH
Abbott Medical
Cardiovascular · 30d
Cleared Oct 29, 2025
SER Pen Carain MicroSystem (MP1209SP)
K253153 · QAI
Su-Ko Technologies, LLC
General & Plastic Surgery · 33d
Cleared Oct 29, 2025
3D Laparoscope
K252697 · GCJ
Guangdong Optomedic Technologies, Inc.
General & Plastic Surgery · 63d
Cleared Oct 29, 2025
AETOS Shoulder System Meta Humeral Prosthesis Size 0
K252416 · KWS
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Oct 29, 2025
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
K252393 · MMI
Ortho-Clinical Diagnostics, Inc.
Chemistry · 90d
Cleared Oct 29, 2025
Telescope Guide Extension Catheter
K252390 · DQY
Medtronic, Ireland
Cardiovascular · 90d
Cleared Oct 29, 2025
Arthrex SutureTak Suture Anchor
K252314 · MBI
Arthrex, Inc.
Orthopedic · 96d
Cleared Oct 29, 2025
LOGIQ E10
K251985 · IYN
GE Medical Systems Ultrasound and...
Radiology · 124d
Cleared Oct 29, 2025
LOGIQ E10s
K251963 · IYN
GE Medical Systems Ultrasound and...
Radiology · 125d
Cleared Oct 29, 2025
Navilas Laser System 577sl (156691)
K251772 · HQF
Od-Os GmbH
Ophthalmic · 141d
Cleared Oct 29, 2025
Synchfix EVT
K251643 · HTN
Wright Medical Technology, Inc....
Orthopedic · 153d
Cleared Oct 29, 2025
SANSA HSAT
K250882 · MNR
Huxley Medical
Cardiovascular · 219d
Cleared Oct 29, 2025
Medi Lift Essential Eye Mask
K250618 · NFO
Ya-Man, Ltd.
Neurology · 243d
Cleared Oct 29, 2025
Meduloc Intramedullary Fracture Fixation (IFF) System
K250316 · JDW
Meduloc, LLC
Orthopedic · 267d
Cleared Oct 28, 2025
Visions® PV .014P RX Digital IVUS Catheter
K253399 · OBJ
Volcano Corporation (Dba Philips...
Cardiovascular · 28d
Cleared Oct 28, 2025
Fine Osteotomy™
K253300 · HRS
Bodycad Laboratories, Inc.
Orthopedic · 29d
Cleared Oct 28, 2025
Navigated Instruments
K252742 · OLO
Tyber Medical, LLC
Orthopedic · 61d
Cleared Oct 28, 2025
TheraSphere 360™ Y-90 Management Platform
K252547 · LLZ
Boston Scientific Corporation
Radiology · 77d
Cleared Oct 28, 2025
Yomi S Robotic System
K252376 · PLV
Neocis, Inc.
Dental · 90d
Cleared Oct 28, 2025
UniSpace® TPLIF Cage
K252351 · MAX
Cg Medtech Co., Ltd.
Orthopedic · 91d
Cleared Oct 28, 2025
ZIRCONOMER P
K252165 · EMA
Shofu Dental Corporation
Dental · 110d
Cleared Oct 28, 2025
VenAir, Sequential Compression System (9P-089000)
K251466 · JOW
Wellell, Inc.
Cardiovascular · 168d
Cleared Oct 28, 2025
PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch
K250275 · GEI
Baylis Medical Technologies, Inc.
General & Plastic Surgery · 270d
Cleared Oct 27, 2025
Electric Breast Pump (HL-3060, F5113)
K252630 · HGX
Fimilla (Shanghai) Maternity & Baby...
Obstetrics & Gynecology · 68d