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"
409–432 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 23, 2024
Lymphedema Compression
K240011 · JOW
Jkh Health Co., Ltd.
Cardiovascular · 52d
Cleared Feb 23, 2024
ENSO (Model 2)
K233784 · NUH
Hinge Health, Inc.
Neurology · 88d
Cleared Feb 22, 2024
Vivatmo pro
K233775 · MXA
Bosch Healthcare Solutions GmbH
Chemistry · 90d
Cleared Feb 22, 2024
NanoDrop Lancet
K223826 · FMK
Drawbridge Health, Inc.
General & Plastic Surgery · 428d
Cleared Feb 15, 2024
Bronchoscope System
K231107 · EOQ
Hunan Endoso Life Technology Co., Ltd.
Ear, Nose, Throat · 302d
Cleared Feb 09, 2024
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use...
K240072 · LZA
Luliang Hongruida Health Protection...
General Hospital · 30d
Cleared Feb 08, 2024
HealthFLD
K233080 · JAK
Nano-X AI , Ltd.
Radiology · 135d
Cleared Feb 07, 2024
FUJIFILM Endoscope Model EB-710XT
K240075 · EOQ
Fujifilm Healthcare Americas Corporation
Ear, Nose, Throat · 28d
Cleared Feb 07, 2024
F&P Optiflow+ Duet Nasal Cannula
K231956 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 219d
Cleared Feb 05, 2024
Smart Fit Knee 3.0T
K233600 · MOS
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 88d
Cleared Feb 02, 2024
Myoaligner Appliance
K230548 · MQC
Myohealth Technologies, LLC
Dental · 339d
Cleared Feb 01, 2024
Surgical Gown (40083)
K233183 · FYA
Ammex-Weida (Hubei) Health and Safety...
General Hospital · 126d
Cleared Jan 26, 2024
Arm-type Fully Automatic Digital Blood Pressure Monitor
K231303 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 266d
Cleared Jan 19, 2024
SIGNA Champion
K233728 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 59d
Cleared Jan 18, 2024
Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
K233242 · NQD
Siemens Healthcare Diagnostics, Inc.
Chemistry · 112d
Cleared Jan 18, 2024
uEXPLORER
K231762 · KPS
Shanghai United Imaging Healthcare...
Radiology · 216d
Cleared Jan 17, 2024
Radify Triage
K231871 · QFM
Envisionit Deepai, Ltd.
Radiology · 205d
Not Cleared Jan 12, 2024
Osteoboost Belt
DEN230015 · QZO
Bone Health Technologies, Inc.
Orthopedic · 329d
Cleared Jan 04, 2024
CEPTRE® Knotted UHMWPE Suture PEEK Anchor
K231033 · MBI
Healthium Medtech Limited
Orthopedic · 268d
Cleared Jan 04, 2024
Pursuant Health Kiosk (G1.D5)
K230996 · DXN
Pursuant Health
Cardiovascular · 272d
Cleared Dec 28, 2023
SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant
K230891 · MBI
Healthium Medtech Limited
Orthopedic · 272d
Cleared Dec 22, 2023
VIO System (V-1000)
K232789 · QZN
Enspectra Health, Inc.
General & Plastic Surgery · 102d
Cleared Dec 21, 2023
syngo Virtual Cockpit (VB10A)
K232744 · LLZ
Siemens Healthcare GmbH
Radiology · 105d
Cleared Dec 21, 2023
FLOWpresso
K223729 · IRP
Medella Health Limited
Physical Medicine · 373d