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"
553–576 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 07, 2023
ANDORATE® Valve Kit
K230932 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 95d
Cleared Jul 07, 2023
AeviceMD
K223382 · DSH
Aevice Health Pte. , Ltd.
Anesthesiology · 242d
Cleared Jul 03, 2023
Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 )
K230569 · FXX
Cardinalhealth
General Hospital · 124d
Cleared Jun 29, 2023
F&P 950 Accessory Breathing Circuit Kits
K221436 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 408d
Cleared Jun 21, 2023
Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110)
K223376 · MEG
Cardinal Health200, LLC
General Hospital · 229d
Cleared Jun 20, 2023
HepaFatSmart (V2.0.0)
K231459 · LNH
Resonance Health Analysis Services...
Radiology · 32d
Cleared Jun 20, 2023
Belle Sensilube
K230781 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 90d
Cleared Jun 16, 2023
Surgical Gown
K222999 · FYA
Hubei Woozon Healthcare Co., Ltd.
General Hospital · 261d
Cleared Jun 16, 2023
F&P 950 Respiratory Humidifier
K220703 · BTT
Fisher & Paykel Healthcare
Anesthesiology · 463d
Cleared Jun 12, 2023
Atellica® CH Diazo Direct Bilirubin (D_DBil)
K223078 · CIG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 255d
Cleared Jun 07, 2023
Ambra PACS
K231360 · LLZ
Dicom Grid Dba Ambra Health
Radiology · 28d
Not Cleared Jun 06, 2023
Cue COVID-19 Molecular Test
DEN220028 · QWB
Cue Health, Inc.
Microbiology · 400d
Cleared Jun 02, 2023
ADVIA Centaur® Anti-Müllerian Hormone (AMH)
K221801 · PQO
Siemens Healthcare Diagnostics, Inc.
Toxicology · 346d
Cleared Jun 02, 2023
vWF Ag
K220728 · GGP
Siemens Healthcare Diagnostics...
Hematology · 445d
Cleared Jun 01, 2023
ANT-X System
K230185 · OWB
Ndr Medical Technology Pte. , Ltd.
Radiology · 129d
Cleared May 30, 2023
Sonic DL
K223523 · LNH
Ge Medical Systems,Llc (Ge Healthcare)
Radiology · 188d
Cleared May 26, 2023
Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs
K213289 · KGO
Ansell Healthcare Products, LLC
General Hospital · 602d
Cleared May 23, 2023
uMR Omega
K230152 · LNH
Shanghai United Imaging Healthcare...
Radiology · 124d
Cleared May 19, 2023
PrevisEA Device
K230769 · DQD
Entac Medical, Inc.
Gastroenterology & Urology · 60d
Cleared May 18, 2023
uMR 570
K230758 · LNH
Shanghai United Imaging Healthcare...
Radiology · 59d
Cleared May 17, 2023
DeepX DermoSight Dermatoscope
K230448 · PSN
Deepx Health, LLC
General & Plastic Surgery · 85d
Cleared May 17, 2023
F&P Solo Mask Range
K223696 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 159d
Cleared May 15, 2023
Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro)
K202993 · PHW
Mmj Labs, LLC
Physical Medicine · 957d
Cleared May 11, 2023
ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
K230280 · KTI
Ga Health Company Limited
Ear, Nose, Throat · 99d