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"
793–816 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Dec 10, 2021
Airvo Nebulizer Adapter
K211560 · CAF
Fisher & Paykel Healthcare Limited
Anesthesiology · 204d
Cleared Dec 10, 2021
EXA
K203743 · LLZ
Konica Minolta Healthcare Americas, Inc.
Radiology · 353d
Cleared Dec 04, 2021
Nitrile Powder Free Blue Examination Gloves, Non-Sterile
K212535 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 115d
Cleared Dec 01, 2021
dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
K212864 · MOS
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 84d
Cleared Nov 24, 2021
Atellica CH Enzymatic Creatinine_3 (ECre3)
K212223 · JFY
Siemens Healthcare Diagnostics, Inc.
Chemistry · 131d
Cleared Nov 24, 2021
Non-Contact Infrared Thermometer, model HL710H
K211744 · FLL
Health & Life Co., Ltd.
General Hospital · 170d
Cleared Nov 24, 2021
Regulora
K211463 · QMY
Metame Health, Inc.
Gastroenterology & Urology · 197d
Cleared Nov 23, 2021
Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub...
K211765 · FYA
Cardinal Health, LLC
General Hospital · 168d
Cleared Nov 23, 2021
PCEA Syringe Set
K211649 · PWH
Baxter Healthcare Corporation
General Hospital · 179d