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
4105–4128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2025
Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
K244030 · BWK
Wuxi Jiajian Medical Instrument Co.,...
Neurology · 88d
Cleared Mar 28, 2025
Bullsai Confirm
K243520 · QQC
Turing Medical Technologies, Inc.
Neurology · 135d
Cleared Mar 28, 2025
Flexi-Seal AIR (with ENFit Connector)
K243228 · KNT
Convatec
Gastroenterology & Urology · 171d
Cleared Mar 28, 2025
INNOVANCE Antithrombin
K242952 · JBQ
Siemens Healthcare Diagnostic...
Hematology · 184d
Cleared Mar 28, 2025
Access Toxo IgG
K242022 · LGD
Beckman Coulter, Inc.
Microbiology · 260d
Cleared Mar 28, 2025
Synthes Graphic Case & Tray System
K241927 · KCT
Synthes GmbH
General Hospital · 270d
Cleared Mar 28, 2025
ImagingRing m (Version 2.0)
K234067 · OWB
Medphoton GmbH
Radiology · 462d
Cleared Mar 28, 2025
Makani Science™ Respiration Monitoring System
K233953 · BZQ
Makani Science, Inc.
Anesthesiology · 469d
Cleared Mar 27, 2025
SelectSite C304 Deflectable Catheter System (C304)
K250558 · DQY
Medtronic, Inc.
Cardiovascular · 30d
Cleared Mar 27, 2025
MallyaD injection pen adapter (MallyaD)
K250555 · QOG
Biocorp Production
General Hospital · 30d
Cleared Mar 27, 2025
HC Biologics Osteopoint Spinal Fixation System
K250092 · NKB
HC Biologics, LLC
Orthopedic · 72d
Cleared Mar 27, 2025
HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102)
K244059 · FOZ
Access Vascular, Inc.
General Hospital · 86d
Cleared Mar 27, 2025
Edwards eSheath Optima introducer set
K244046 · DYB
Edwards Lifesciences
Cardiovascular · 87d
Cleared Mar 27, 2025
iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System
K243768 · MBH
Restor3D, Inc.
Orthopedic · 111d
Cleared Mar 27, 2025
Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B,...
K243708 · FGB
Scivita Medical Technology Co., Ltd.
Gastroenterology & Urology · 115d
Cleared Mar 27, 2025
Nurochek-Pro System
K243426 · PIW
Headsafe Mfg Pty, Ltd.
Neurology · 143d
Cleared Mar 27, 2025
Salix Central
K243038 · QIH
Artrya Limited
Radiology · 181d
Cleared Mar 27, 2025
V5med Lung AI
K242919 · OEB
V5med, Inc.
Radiology · 184d
Cleared Mar 27, 2025
AI-Rad Companion Organs RT
K242745 · QKB
Siemens Healthcare GmbH
Radiology · 197d
Cleared Mar 27, 2025
HyperSuture White/Green Extension Line
K242201 · GAT
Threadstone, LLC
General & Plastic Surgery · 244d
Cleared Mar 27, 2025
Crossloop
K241962 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 267d
Cleared Mar 27, 2025
Levina Pelvic Floor Muscle Stimulator (RS-48)
K241862 · KPI
Zmi Electronics , Ltd.
Gastroenterology & Urology · 273d
Cleared Mar 27, 2025
StarFormer (M008-3T)
K241785 · QPL
Fotona D.O.O.
Physical Medicine · 280d
Cleared Mar 26, 2025
AC3™ Range™ Intra-Aortic Balloon Pump
K250542 · DSP
Arrow International, LLC
Cardiovascular · 30d