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"
457–480 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Dec 20, 2023
uOmnispace.MI
K233176 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 83d
Cleared Dec 19, 2023
PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
K233132 · FLE
Primus Sterilizer Company, LLC
General Hospital · 83d
Cleared Dec 15, 2023
Videa Dental Assist
K232384 · MYN
Videahealth, Inc.
Radiology · 129d
Cleared Dec 15, 2023
EW10-EC02 Endoscopy Support Program
K230751 · QNP
Fujifilm Corporation
Gastroenterology & Urology · 273d
Cleared Dec 14, 2023
MedHealth DVT compression Devices MHH900S/MHH900E
K231801 · JOW
Medhealth Medical Limited
Cardiovascular · 177d
Cleared Dec 13, 2023
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
K233663 · CFN
Siemens Healthcare Diagnostics...
Immunology · 28d
Cleared Dec 13, 2023
Endoscopic Ultrasonic Probe (P2612S-L)
K231666 · ITX
Fujifilm Healthcare Americas Corporation
Radiology · 189d
Cleared Dec 05, 2023
Aurelia Surgical Mask ASTM Level 1
K231005 · FXX
Supermax Healthcare Canada-Supermax...
General Hospital · 242d
Not Cleared Dec 04, 2023
Sonu
DEN230045 · QZC
Sound Health Systems, Inc.
Ear, Nose, Throat · 171d