FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

5,274 results for "health"
361–384 of 5,274
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 10, 2024
INNOVANCE Anti-Xa (OPPU05)
K240315 · QLU
Siemens Healthcare Diagnostics...
Hematology · 251d
Not Cleared Oct 08, 2024
Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection...
DEN230076 · QXY
Omron Healthcare, Inc.
Cardiovascular · 330d
Cleared Oct 04, 2024
Electroporation System (N3000)
K240376 · OAB
Surgnova Healthcare Technologies...
General & Plastic Surgery · 240d
Cleared Sep 27, 2024
CAC (gated) Algorithm
K240369 · JAK
BunkerHill Health
Radiology · 233d
Cleared Sep 27, 2024
AMC Health CareConsole
K233446 · MWI
Amc Health
Cardiovascular · 344d
Cleared Sep 24, 2024
uAI Easy Triage ICH
K242292 · QAS
Shanghai United Imaging Intelligence...
Radiology · 53d
Cleared Sep 24, 2024
Happy Ring Health Monitoring System
K240236 · MWI
Happy Health, Inc.
Cardiovascular · 239d
Cleared Sep 06, 2024
Orchid Safety Release Valve™
K241415 · QOI
Linear Health Sciences, LLC
General Hospital · 112d
Cleared Sep 05, 2024
Novum IQ Syringe Pump (40800BAXUS)
K242390 · FRN
Baxter Healthcare Corporation
General Hospital · 24d
Cleared Sep 04, 2024
FUJIFILM Endoscope Model EG-840N
K240142 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 230d
Cleared Aug 30, 2024
uMI Panorama
K241585 · KPS
Shanghai United Imaging Healthcare...
Radiology · 88d
Cleared Aug 30, 2024
Vave Wireless Ultrasound System
K241051 · IYN
Vave Health, Inc.
Radiology · 135d
Cleared Aug 30, 2024
Daylight
K233872 · SCP
Big Health, Inc.
Neurology · 267d
Cleared Aug 23, 2024
Cardinal Health Nitrile Exam Gloves
K241780 · LZA
Cardinal Health200, LLC
General Hospital · 64d
Cleared Aug 23, 2024
Nova Micro Pillows Mask Small A Model (NVP1SA)
K233829 · BZD
Fisher and Paykel Healthcare Limited
Anesthesiology · 266d
Cleared Aug 19, 2024
HealthCCSng
K241440 · JAK
Nano-X AI , Ltd.
Radiology · 90d
Cleared Aug 15, 2024
uMI Panvivo
K241596 · KPS
Shanghai United Imaging Healthcare...
Radiology · 73d
Cleared Aug 15, 2024
CoLumbo
K241211 · QIH
Smart Soft Healthcare
Radiology · 107d
Cleared Aug 13, 2024
ECHELON Synergy MRI System
K241429 · LNH
Fujifilm Healthcare Corporation
Radiology · 84d
Cleared Aug 09, 2024
F&P Optiflow Flow Diverter
K234053 · CBP
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 231d
Cleared Aug 09, 2024
F&P Airvo 3 NIV (PT311US)
K233643 · MNT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 270d
Cleared Aug 08, 2024
SynthVISION 1.0.0
K240724 · LLZ
Synthesis Health Intelligence, Inc.
Radiology · 143d
Cleared Aug 08, 2024
F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility...
K234058 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 230d
Cleared Aug 06, 2024
myAblation Guide (VB80A)
K240796 · QTZ
Siemens Healthcare GmbH
Radiology · 137d