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"
721–744 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 03, 2022
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
K214089 · ODG
Fujifilm Corporation
Radiology · 157d
Cleared Jun 01, 2022
FROG Forceps Valve (VAL1-F1-100)
K221264 · ODC
Fujifilm Medwork GmbH
Gastroenterology & Urology · 30d
Cleared May 25, 2022
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K210655 · OWQ
Innovative Health, LLC
Cardiovascular · 447d
Cleared May 23, 2022
Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
K220155 · LZA
Motex Healthcare (Anhui) Co., Ltd.
General Hospital · 124d
Cleared May 23, 2022
SCENARIA View
K213829 · JAK
Fujifilm Healthcare Corporation
Radiology · 166d
Cleared May 19, 2022
Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
K220370 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 99d
Cleared May 19, 2022
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
K213174 · PIF
Cardinalhealth
Gastroenterology & Urology · 233d
Cleared May 17, 2022
Heel Stick Safety Lancet (HHZ-II, HHZ-III)
K220372 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 97d
Cleared May 12, 2022
Saige-Dx
K220105 · QDQ
DeepHealth, Inc.
Radiology · 120d
Cleared May 11, 2022
Durex Condom with Benzocaine
K211152 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 387d
Cleared May 06, 2022
NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar...
K212289 · QCI
Neuronetics, Inc.
Neurology · 289d
Cleared May 03, 2022
Orchid Safety Release Valve(TM)
K212064 · QOI
Linear Health Sciences, LLC
General Hospital · 305d
Cleared Apr 29, 2022
Oxehealth Vital Signs
K220899 · QME
Oxehealth Limited
Cardiovascular · 32d
Cleared Apr 29, 2022
Spectrum IQ Infusion System with Dose IQ Safety Software
K220417 · FRN
Baxter Healthcare Corporation
General Hospital · 74d
Cleared Apr 29, 2022
ARIETTA 50
K220295 · IYN
Fujifilm Healthcare Corporation
Radiology · 86d
Cleared Apr 29, 2022
Monarch Platform, Urology
K213334 · FGB
Auris Health, Inc.
Gastroenterology & Urology · 205d
Cleared Apr 27, 2022
Philips Incisive CT
K212441 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 266d
Cleared Apr 22, 2022
HealthOST
K213944 · JAK
Nanoxai , Ltd.
Radiology · 126d
Cleared Apr 22, 2022
ATUSA™ Automated 3D Breast Ultrasound System
K213620 · IYO
Isono Health, Inc.
Radiology · 157d
Cleared Apr 22, 2022
F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
K212031 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 297d
Cleared Apr 21, 2022
Videa Caries Assist
K213795 · MYN
Videahealth, Inc.
Radiology · 136d
Cleared Apr 15, 2022
AI-Rad Companion Brain MR
K213706 · QIH
Siemens Healthcare GmbH
Radiology · 142d
Cleared Apr 13, 2022
CARESCAPE B450, E-musb
K213363 · MHX
GE Healthcare Finland Oy
Cardiovascular · 183d
Cleared Apr 13, 2022
Carescape B850, E-musb
K213336 · MHX
GE Healthcare Finland Oy
Cardiovascular · 189d