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
3481–3504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 2025
SnugFit ASA Extension
K251933 · MBI
Medacta International S.A.
Orthopedic · 7d
Cleared Jul 01, 2025
Momentum® Posterior Spinal Fixation System
K251719 · NKB
Ulrich Medical USA, Inc.
Orthopedic · 27d
Cleared Jul 01, 2025
Arthrex iBalance Partial Knee System
K251453 · HSX
Arthrex, Inc.
Orthopedic · 50d
Cleared Jul 01, 2025
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM)
K251212 · LJS
Access Vascular, Inc.
General Hospital · 74d
Cleared Jul 01, 2025
MiniMed 780G insulin pump
K251032 · QFG
Medtronic Minimed, Inc.
Chemistry · 89d
Cleared Jul 01, 2025
Cure Twist Female 8 Catheter (T8)
K250699 · EZD
Convatec
Gastroenterology & Urology · 116d
Cleared Jul 01, 2025
StrokeSENS ASPECTS Software Application
K250221 · POK
Circle Cardiovascular Imaging, Inc.
Radiology · 158d
Cleared Jul 01, 2025
Endoscopic Camera System
K250204 · FET
Shenzhen Sophway Technology Co., Ltd.
General & Plastic Surgery · 158d
Cleared Jul 01, 2025
Felix NeuroAI System
K250096 · QBC
Fasikl Incorporated
Neurology · 168d
Cleared Jul 01, 2025
droplet® personal lancets
K250016 · QRK
Htl-Strefa S.A
General & Plastic Surgery · 179d
Cleared Jul 01, 2025
Bunkerhill Abdominal Aortic Quantification (AAQ)
K243779 · QIH
BunkerHill Health
Radiology · 204d
Cleared Jul 01, 2025
SonoMSK
K243690 · BSP
PAJUNK GmbH Medizintechnologie
Anesthesiology · 214d
Cleared Jul 01, 2025
Alinity m CMV
K243485 · PAB
Abbott Molecular, Inc.
Microbiology · 235d
Cleared Jun 30, 2025
Otsuka Digital Feedback Device
K251088 · OZW
Otsuka America Pharmaceutical, Inc.
Cardiovascular · 82d
Cleared Jun 30, 2025
Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07,...
K251000 · OHT
Shenzhen Chuangtong Yigou Technology...
General & Plastic Surgery · 90d
Cleared Jun 30, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K250990 · JWY
Thermo Fisher Scientific
Microbiology · 91d
Cleared Jun 30, 2025
aprevo® posterior/transforaminal lumbar interbody fusion device
K250987 · MAX
Carlsmed, Inc.
Orthopedic · 91d
Cleared Jun 30, 2025
EchoConfidence (USA)
K250670 · QIH
Mycardium AI Limited
Radiology · 117d
Cleared Jun 30, 2025
PIUR tUS inside
K250484 · QIH
Piur Imaging GmbH
Radiology · 131d
Cleared Jun 30, 2025
HeroTracker Sense
K250022 · CAF
Voluntis
Anesthesiology · 178d
Cleared Jun 30, 2025
Synapse PACS (7.5)
K243647 · QIH
Fujifilm Healthcare Americas Corporation
Radiology · 216d
Cleared Jun 29, 2025
Primum Hydrophilic Guiding Catheter
K250972 · DQY
Pendracare
Cardiovascular · 90d
Cleared Jun 27, 2025
T3 Pro Implants– ZimVie Packaging System
K251660 · DZE
Biomet 3i, LLC
Dental · 28d
Cleared Jun 27, 2025
BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded...
K251654 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 28d