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"
625–648 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 10, 2022
FUJIFILM Endoscope Model EB-710P
K220957 · EOQ
Fujifilm Corporaton
Ear, Nose, Throat · 223d
Cleared Nov 08, 2022
Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
K222734 · OCX
Diversatek Healthcare
Gastroenterology & Urology · 60d
Cleared Nov 07, 2022
Durex Patronus CloseFit, Durex Patronus Regular
K220489 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 258d
Cleared Nov 07, 2022
Eclipse MINI Model 98900
K212317 · MWJ
Spacelabs Healthcare, Ltd.
Cardiovascular · 469d
Cleared Nov 02, 2022
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K223320 · LZA
Lingshi Hongruida Health Protection...
General Hospital · 5d
Cleared Nov 01, 2022
POSE™ Health Care Surgical Mask
K223270 · FXX
America?S Supply Chains
General Hospital · 8d
Cleared Nov 01, 2022
Current Health System
K222550 · MSX
Current Health , Ltd.
Cardiovascular · 70d
Cleared Oct 27, 2022
AlphaID™ At Home Genetic Health Risk Service
K221420 · PTA
Progenika Biopharma S.A., A Grifols...
Immunology · 164d
Cleared Oct 27, 2022
uMR Omega with uWS-MR-MRS
K220332 · LNH
Shanghai United Imaging Healthcare...
Radiology · 265d
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