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

5,275 results for "health"
433–456 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 29, 2024
Dose IQ Safety Software
K230665 · PHC
Baxter Healthcare Corporation
General Hospital · 385d
Cleared Mar 29, 2024
Novum IQ Large Volume Pump
K211122 · FRN
Baxter Healthcare Corporation
General Hospital · 1079d
Cleared Mar 28, 2024
CORE 500 Digital Stethoscope
K233609 · DQD
Eko Health, Inc.
Cardiovascular · 136d
Cleared Mar 28, 2024
Eko Low Ejection Fraction Tool (ELEFT)
K233409 · QYE
Eko Health, Inc.
Cardiovascular · 174d
Cleared Mar 22, 2024
uMR Omega
K240540 · LNH
Shanghai United Imaging Healthcare...
Radiology · 25d
Cleared Mar 22, 2024
The Vest APX System (PVAPX1)
K233441 · BYI
Baxter Healthcare Corportation
Anesthesiology · 156d
Cleared Mar 22, 2024
Corsano CardioWatch 287-2 System
K232548 · MSX
Corsano Health B.V.
Cardiovascular · 212d
Cleared Mar 21, 2024
AI-Rad Companion (Pulmonary)
K233753 · JAK
Siemens Healthcare GmbH
Radiology · 120d
Cleared Mar 18, 2024
nCommand Lite System
K233660 · LLZ
Ionic Health
Radiology · 124d
Cleared Mar 13, 2024
IMMULITE® 2000 BR-MA
K233946 · MOI
Siemens Healthcare Diagnostics...
Immunology · 90d
Cleared Mar 12, 2024
DRX-Evolution Plus System
K233381 · KPR
Carestream Health, Inc.
Radiology · 162d
Cleared Mar 12, 2024
MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A
K231849 · KDJ
Baxter Healthcare
Gastroenterology & Urology · 263d
Cleared Mar 01, 2024
Insignis™ Syringe Infusion System
K232328 · FPA
Innovative Health Sciences, LLC
General Hospital · 211d
Cleared Feb 29, 2024
Powder Free Nitrile Examination Gloves (Blue), Tested For Use With...
K240051 · LZA
Lingshi Hongruida Health Protection...
General Hospital · 52d
Cleared Feb 27, 2024
Peace N Quiet (0.7.0)
K233435 · KLW
Pnq Health
Ear, Nose, Throat · 137d
Cleared Feb 23, 2024
Lymphedema Compression
K240011 · JOW
Jkh Health Co., Ltd.
Cardiovascular · 52d
Cleared Feb 23, 2024
ENSO (Model 2)
K233784 · NUH
Hinge Health, Inc.
Neurology · 88d
Cleared Feb 22, 2024
Vivatmo pro
K233775 · MXA
Bosch Healthcare Solutions GmbH
Chemistry · 90d
Cleared Feb 22, 2024
NanoDrop Lancet
K223826 · FMK
Drawbridge Health, Inc.
General & Plastic Surgery · 428d
Cleared Feb 15, 2024
Bronchoscope System
K231107 · EOQ
Hunan Endoso Life Technology Co., Ltd.
Ear, Nose, Throat · 302d
Cleared Feb 09, 2024
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use...
K240072 · LZA
Luliang Hongruida Health Protection...
General Hospital · 30d
Cleared Feb 08, 2024
HealthFLD
K233080 · JAK
Nano-X AI , Ltd.
Radiology · 135d
Cleared Feb 07, 2024
FUJIFILM Endoscope Model EB-710XT
K240075 · EOQ
Fujifilm Healthcare Americas Corporation
Ear, Nose, Throat · 28d
Cleared Feb 07, 2024
F&P Optiflow+ Duet Nasal Cannula
K231956 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 219d