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"
841–864 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 28, 2021
Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C....
K212320 · OMP
3M Healthcare Business Group
General & Plastic Surgery · 64d
Cleared Sep 28, 2021
Advisor Pro Platform
K210561 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 215d
Cleared Sep 28, 2021
Electrically Powered Wheelchair -Model HP358E
K201855 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 449d
Cleared Sep 27, 2021
Disposable Vinyl Examination Gloves
K211236 · LYZ
Tangshan Hongyun Healthcare Products...
General Hospital · 154d
Cleared Sep 26, 2021
Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
K201592 · KGO
Cardinal Health200, LLC
General Hospital · 471d
Cleared Sep 23, 2021
JiveX (Model Number / Release: 5.3)
K212321 · LLZ
Visus Health IT GmbH
Radiology · 59d
Cleared Sep 23, 2021
OnGuard2 Chemfort Closed Administration (CADM)
K210707 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 197d
Cleared Sep 17, 2021
Deep Learning Image Reconstruction
K212067 · JAK
Ge Healthcare Japan Corporation
Radiology · 77d
Cleared Sep 15, 2021
Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters
K211276 · NLH
Innovative Health, LLC
Cardiovascular · 141d
Cleared Sep 15, 2021
HealthCCSng
K210085 · JAK
Zebra Medical Vision, Ltd.
Radiology · 245d
Cleared Sep 13, 2021
KONICAMINOLTA DI-X1
K212685 · LLZ
Konica Minolta, Inc.
Radiology · 20d
Cleared Sep 13, 2021
Harmony Referral System
K210396 · NFJ
Topcon Healthcare Solutions EMEA Oy
Ophthalmic · 215d
Cleared Sep 10, 2021
LOGIQ E10
K211488 · IYN
Ge Healthcare
Radiology · 120d
Cleared Sep 10, 2021
Kinepict Medical Imaging Tool 4.0
K202056 · LLZ
Kinepict Health, Ltd.
Radiology · 413d
Cleared Sep 08, 2021
Leva Pelvic Health System
K212495 · HIR
Renovia, Inc.
Gastroenterology & Urology · 30d
Cleared Sep 08, 2021
Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM
K211127 · DXN
Health & Life Co., Ltd.
Cardiovascular · 145d
Cleared Sep 03, 2021
WoundExpress
K211200 · JOW
Huntleigh Healthcare , Ltd.
Cardiovascular · 134d
Cleared Sep 03, 2021
Current Health Monitoring System Gen 2 (G2)
K210133 · MSX
Current Health
Cardiovascular · 227d
Cleared Sep 01, 2021
Welspun Health Surgical Mask
K211536 · FXX
Welspun India Limited
General Hospital · 106d
Cleared Aug 31, 2021
Adhesive Electrode
K210448 · GXY
Shaoxing Yingtuo Healthcare Co., Ltd.
Neurology · 196d
Cleared Aug 28, 2021
Nitrile Blue Powder-free Examination Glove
K211390 · LZA
Cardinal Health200, LLC
General Hospital · 115d
Cleared Aug 27, 2021
MyoSPECT, MyoSpect ES
K212004 · KPS
Ge Healthcare
Radiology · 60d
Cleared Aug 27, 2021
LOGIQ E10s, LOGIQ Fortis
K211524 · IYN
Ge Healthcare
Radiology · 102d
Not Cleared Aug 27, 2021
Canary Tibial Extension with Canary Health Implanted Reporting Processor...
DEN200064 · QPP
Canary Medical, Inc.
Orthopedic · 312d