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

5,198 results for "health"
313–336 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 01, 2024
Over-tube (TR-1108A)
K243091 · FED
Fujifilm Corporation
Gastroenterology & Urology · 32d
Cleared Nov 01, 2024
uDR 780i
K241068 · KPR
Shanghai United Imaging Healthcare...
Radiology · 196d
Cleared Oct 28, 2024
Sterile Lancets for Single Use
K242622 · QRK
Ningbo Caremed Medical Products Co.,...
General & Plastic Surgery · 55d
Cleared Oct 18, 2024
Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator
K233054 · NUH
Well-Life Healthcare Limited
Neurology · 389d
Cleared Oct 17, 2024
Electrically powered wheelchair (HP202)
K241337 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 157d
Cleared Oct 16, 2024
Electrically powered wheelchair
K241632 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 132d
Cleared Oct 11, 2024
Hood (DH-083ST)
K242779 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 28d
Cleared Oct 11, 2024
PPH Saliva Collection Kit
K240797 · QBD
Permantis Public Health
Microbiology · 203d
Cleared Oct 10, 2024
uDR 380i Pro
K242515 · IZL
Shanghai United Imaging Healthcare...
Radiology · 48d
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