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"
769–792 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 18, 2022
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use...
K213440 · LZA
Luliang Hongruida Health Protection...
General Hospital · 116d
Cleared Feb 18, 2022
ExamVue Duo
K213057 · KPR
Jpi Healthcare Co, Ltd.
Radiology · 149d
Cleared Feb 17, 2022
Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab...
K213972 · DQK
Ge Healthcare Information...
Cardiovascular · 59d
Cleared Feb 17, 2022
Voluson P6, Voluson P8
K213689 · IYN
Ge Healthcare
Radiology · 86d
Cleared Feb 17, 2022
Durex Patronus Wide
K213647 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 90d
Cleared Feb 11, 2022
SIGNA Artist Evo
K213603 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 88d
Cleared Feb 04, 2022
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
K220053 · KGE
Fujifilm Corporation
Gastroenterology & Urology · 29d
Cleared Feb 04, 2022
Revolution Ascend
K213938 · JAK
Ge Healthcare Japan Corporation
Radiology · 50d
Cleared Jan 31, 2022
SKR 3000
K213908 · MQB
Konica Minolta, Inc.
Radiology · 48d
Cleared Jan 28, 2022
ShinEvac Smoke Evacuation Pencil
K213317 · GEI
Shining World Health Care Co., Ltd.
General & Plastic Surgery · 116d
Cleared Jan 28, 2022
iHealth infrared Ear thermometer PT5
K212598 · FLL
Andon Health Co, Ltd.
General Hospital · 165d
Cleared Jan 28, 2022
Optiflow Oxygen Kit
K211096 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 290d
Cleared Jan 24, 2022
Revaclear 500, Revaclear 400, Revaclear 300
K213639 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 67d
Cleared Jan 21, 2022
Universal DR 1748
K214030 · MQB
Konica Minolta Healthcare Americas, Inc.
Radiology · 29d
Cleared Jan 20, 2022
SIGNA Hero
K213668 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 59d
Cleared Jan 19, 2022
Caption Interpretation Automated Ejection Fraction Software
K210747 · QIH
Caption Health
Radiology · 313d
Cleared Jan 18, 2022
HP458E Electrically Powered Wheelchair
K212503 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 162d
Cleared Jan 16, 2022
SIGNA Prime
K211980 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 205d
Cleared Jan 14, 2022
Eclipse II with Smart Noise Cancellation
K213307 · MQB
Carestream Health, Inc.
Radiology · 102d
Cleared Jan 14, 2022
Surgical Face Mask
K212913 · FXX
Jiangxi Ganlong Pharmaceutical Co., Ltd.
General Hospital · 123d
Cleared Jan 13, 2022
Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
K213642 · IYN
Ge Healthcare
Radiology · 56d
Cleared Jan 12, 2022
Straight Arm DDR
K214012 · KPR
Konica Minolta Healthcare Americas, Inc.
Radiology · 21d
Cleared Jan 12, 2022
andorate Suction Valve, andorate Air/Water Valve
K213095 · ODC
Ga Health Company Limited
Gastroenterology & Urology · 110d
Cleared Jan 11, 2022
Medical Examination Gloves
K213168 · LZA
Shandong Huiwosheng Health Technology...
General Hospital · 105d