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"
745–768 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Jan 10, 2022
Sheng Jing Tang Surgical Mask
K211260 · FXX
Liaoning Shengjingtang Biotechnology...
General Hospital · 259d
Cleared Jan 05, 2022
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully...
K212115 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 182d
Cleared Jan 04, 2022
Disposable Medical Surgical Mask
K212375 · FXX
Jiangxi Bestgrand Health Technology...
General Hospital · 158d
Cleared Jan 04, 2022
HP358EA Electrically Powered Wheelchair
K211647 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 221d
Cleared Dec 29, 2021
LiverSmart
K213776 · PCS
Resonance Health Analysis Services...
Radiology · 27d
Cleared Dec 24, 2021
Nitrile Examination Golves Powder Free
K212921 · LZA
Jiangsu Standard Health Co.,Ltd
General Hospital · 101d
Cleared Dec 23, 2021
SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE...
K213547 · HIS
Ttk Healthcare Limited
Obstetrics & Gynecology · 45d
Cleared Dec 22, 2021
Claritas iPET
K213140 · LLZ
Claritas Healthtech Pte, Ltd.
Radiology · 86d
Cleared Dec 20, 2021
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
K212776 · NLG
Innovative Health, LLC
Cardiovascular · 110d
Cleared Dec 20, 2021
3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit:...
K211521 · OMP
3M Healthcare Business Group
General & Plastic Surgery · 217d
Cleared Dec 15, 2021
HealthPPT
K211803 · QFM
Zebra Medical Vision, Ltd.
Radiology · 187d
Cleared Dec 15, 2021
Transcutaneous Electrical Nerve Stimulator
K210223 · NUH
Top-Rank Health Care Co., Ltd.
Neurology · 321d
Cleared Dec 14, 2021
Surgical Face Mask
K212574 · FXX
Xiantao Deming Healthcare Products...
General Hospital · 120d
Cleared Dec 11, 2021
Medical Surgical Mask
K212867 · FXX
Nanchang Kanghua Health Materials...
General Hospital · 94d
Cleared Dec 10, 2021
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar,...
K213543 · OBP
Neuronetics, Inc.
Neurology · 32d