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"
385–408 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 12, 2024
OASIS MRI System
K240571 · LNH
Fujifilm Healthcare Corporation
Radiology · 43d
Cleared Apr 12, 2024
Disposable Extension Set
K222766 · FPA
Shandong Ande Healthcare Apparatus...
General Hospital · 577d
Cleared Apr 11, 2024
True Enhance DL
K233698 · JAK
Ge Healthcare Japan Corporation
Radiology · 146d
Cleared Apr 10, 2024
uMR 680
K240744 · LNH
Shanghai United Imaging Healthcare...
Radiology · 23d
Cleared Apr 10, 2024
Keikku Electronic stethoscope
K233313 · DQD
Lapsi Health Holding B.V.
Cardiovascular · 194d
Cleared Apr 04, 2024
ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
K233050 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 192d
Cleared Apr 04, 2024
Reprocessed VersaCross Steerable Sheath
K232037 · PNE
Innovative Health, LLC
Cardiovascular · 269d
Cleared Apr 03, 2024
Oxevision Sleep Device
K233618 · LEL
Oxehealth Limited
Neurology · 142d
Cleared Apr 02, 2024
Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy...
K240080 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 82d
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