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"
721–744 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 03, 2022
Air Compression Leg Massager (model: FE-7204B)
K211850 · IRP
Xiamen Healthpal Electronic Co.,Ltd
Physical Medicine · 261d
Cleared Mar 02, 2022
N Latex FLC kappa, N Latex FLC lambda
K212379 · DFH
Siemens Healthcare Diagnostics...
Immunology · 212d
Cleared Mar 01, 2022
Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry,...
K213400 · NUC
Rb Health (Us)
Obstetrics & Gynecology · 134d
Cleared Mar 01, 2022
Wrist-type Fully Automatic Digital Blood Pressure Monitor
K213189 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 153d
Cleared Mar 01, 2022
Disposable Sterile Syringe with Safety Needle
K211484 · MEG
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 293d
Cleared Feb 24, 2022
PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing
K210135 · FRO
3M Healthcare Business Group
General & Plastic Surgery · 401d
Cleared Feb 19, 2022
Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For...
K214110 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 52d
Cleared Feb 19, 2022
Well-Life TENS/EMS/Heating Stimulator
K213091 · NUH
Well-Life Healthcare Limited
Neurology · 148d
Cleared Feb 19, 2022
Heartland Health Surgical Mask
K212366 · FXX
Heartland Health Products
General Hospital · 204d
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