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

5,276 results for "health"
913–936 of 5,276
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 18, 2021
Personal Lubricant Jelly
K202667 · NUC
Nantong Health & Beyond Hygienic...
Obstetrics & Gynecology · 246d
Cleared May 06, 2021
Dr. Yglo Wart Remover
K210529 · GEH
Theotclab Healthcare B.V.
General & Plastic Surgery · 72d
Cleared May 06, 2021
ImagePilot
K210066 · LLZ
Konica Minolta, Inc.
Radiology · 115d
Cleared May 04, 2021
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed...
K203655 · NLH
Innovative Health, LLC
Cardiovascular · 140d
Cleared Apr 30, 2021
HYPER AiR
K210001 · KPS
Shanghai United Imaging Healthcare...
Radiology · 116d
Cleared Apr 29, 2021
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs...
K210944 · LZA
Harbour Health, LLC
General Hospital · 30d
Cleared Apr 26, 2021
Vital Sign Monitoring Sensor (Model :XK300)
K202464 · DRT
Xandar Kardian, Inc.
Cardiovascular · 242d
Cleared Apr 16, 2021
Saige-Q
K203517 · QFM
DeepHealth, Inc.
Radiology · 137d
Cleared Apr 15, 2021
SKORE (Colors & Flavors), SKORE (Colors)
K202403 · HIS
Ttk Healthcare Limited
Obstetrics & Gynecology · 237d
Cleared Apr 14, 2021
F&P Visairo NIV Mask Range
K203449 · CBK
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 142d
Cleared Apr 09, 2021
HYPER Focus
K210418 · KPS
Shanghai United Imaging Healthcare...
Radiology · 57d
Cleared Apr 02, 2021
Eclipse II with Smart Noise Cancellation
K202441 · MQB
Carestream Health, Inc.
Radiology · 219d
Cleared Apr 01, 2021
Omron Model BP7900 Blood Pressure Monitor + EKG
K202228 · DXN
Omron Healthcare, Inc.
Cardiovascular · 237d
Cleared Mar 31, 2021
syngo.CT Lung CAD
K203258 · OEB
Siemens Healthcare GmbH
Radiology · 146d
Cleared Mar 29, 2021
StarGuide
K210173 · KPS
Ge Healthcare
Radiology · 66d
Cleared Mar 26, 2021
Spacelabs Lifescreen PRO Analyzer
K201921 · DQK
Spacelabs Healthcare, Ltd.
Cardiovascular · 259d
Cleared Mar 26, 2021
MyCRO Band
K201426 · MVA
Otto Bock Healthcare LP
Neurology · 301d
Not Cleared Mar 26, 2021
Oxehealth Vital Signs
DEN200019 · QME
Oxehealth Limited
Cardiovascular · 364d
Cleared Mar 25, 2021
Surgical Masks, Model SNN200640 & MN112
K203776 · FXX
Sq Medical Supplies, Inc.
General Hospital · 87d
Cleared Mar 23, 2021
ICU Health Surgical Mask
K203064 · FXX
Plastikon Industries
General Hospital · 165d
Cleared Mar 19, 2021
Patient Examination Gloves
K203593 · LZA
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 100d
Cleared Mar 16, 2021
F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling
K201723 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 266d
Cleared Mar 11, 2021
Monarch Bronchoscope
K203614 · QNW
Auris Health, Inc., A Johnson and...
Ear, Nose, Throat · 91d
Cleared Mar 10, 2021
AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
K201809 · KDI
Baxter Healthcare Corportation
Gastroenterology & Urology · 252d