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"
673–696 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 26, 2022
Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
K222498 · LZA
Humanwell Healthcare Group Medical...
General Hospital · 69d
Cleared Oct 25, 2022
3Dicom MD
K222470 · LLZ
Singular Health Pty, Ltd.
Radiology · 70d
Cleared Oct 18, 2022
TRUEdraw Lancing Device, Mini Lancing Device
K221072 · QRL
Trividia Health
General & Plastic Surgery · 189d
Cleared Oct 14, 2022
syngo.via View&GO
K221501 · LLZ
Siemens Healthcare GmbH
Radiology · 144d
Cleared Oct 12, 2022
Durex Penck III Regular
K222068 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 90d
Cleared Oct 07, 2022
Disposable Sterile Syringe with permanently attached needle
K220057 · MEG
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 274d
Cleared Oct 06, 2022
Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
K222080 · OWB
Sg Healthcare Co, Ltd.
Radiology · 83d
Cleared Oct 03, 2022
PCA Syringe Sets
K212262 · FPA
Baxter Healthcare Corporation
General Hospital · 440d
Cleared Sep 30, 2022
uDR 380i Pro
K222339 · IZL
Shanghai United Imaging Healthcare...
Radiology · 58d
Cleared Sep 30, 2022
8mm Monopolar Curved Scissors
K210478 · QSM
Iconocare Health
General & Plastic Surgery · 588d
Not Cleared Sep 29, 2022
INNOVANCE VWF Ac
DEN200067 · QTY
Siemens Healthcare Diagnostics...
Hematology · 701d
Cleared Sep 24, 2022
Single-use medical latex examination gloves (LG100)
K222693 · LYY
Fitone Latex Products Co., Ltd....
General Hospital · 18d
Cleared Sep 13, 2022
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
K221748 · KGO
Guilin Hbm Health Protections, Inc.
General Hospital · 89d
Cleared Sep 06, 2022
Spectrum IQ Infusion System with Dose IQ Safety Software
K222048 · FRN
Baxter Healthcare Corporation
General Hospital · 56d
Cleared Sep 02, 2022
Omni Legend
K221932 · KPS
Ge Healthcare
Radiology · 63d
Cleared Aug 30, 2022
Novum IQ Syringe Pump
K211125 · FRN
Baxter Healthcare Corporation
General Hospital · 502d
Cleared Aug 30, 2022
Dose IQ Safety Software
K211124 · PHC
Baxter Healthcare Corporation
General Hospital · 502d
Cleared Aug 26, 2022
Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
K220262 · PRI
Siemens Healthcare Diagnostics, Inc.
Microbiology · 207d
Cleared Aug 24, 2022
NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System,...
K222230 · OBP
Neuronetics, Inc.
Neurology · 30d
Cleared Aug 19, 2022
FUJIFILM Ultrasonic Endoscope EG-740UT
K221238 · ODG
Fujifilm Corporation
Gastroenterology & Urology · 112d
Cleared Aug 11, 2022
AI-Rad Companion (Pulmonary)
K213713 · JAK
Siemens Healthcare GmbH
Radiology · 260d
Cleared Aug 06, 2022
Reprocesses Umbilical Cable
K221854 · NLH
Innovative Health, LLC
Cardiovascular · 40d
Cleared Aug 04, 2022
Endoscope Model EG-580UT and Endoscope Model EG-580UR
K221952 · ODG
Fujifilm Corporation
Gastroenterology & Urology · 30d
Cleared Aug 04, 2022
Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
K220524 · NUH
Well-Life Healthcare Limited
Neurology · 162d