FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
793–816 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 18, 2021
Change Healthcare Cardiology
K212528 · LLZ
Change Healthcare Israel , Ltd.
Radiology · 68d
Cleared Oct 18, 2021
Surgical Gown
K211809 · FYA
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 129d
Cleared Oct 13, 2021
Video Endoscopy System, 3D Video Endoscopy System
K210116 · HET
Surgnova Healthcare Technologies...
Obstetrics & Gynecology · 267d
Cleared Oct 12, 2021
Nitrile examination gloves
K211927 · LZA
Fitone Latex Products Co., Ltd....
General Hospital · 112d
Cleared Oct 07, 2021
OASIS MRI System
K211406 · LNH
Hitachi Healthcare Americas
Radiology · 154d
Cleared Oct 06, 2021
ZinRom Nitrile examination gloves
K211719 · LZA
Changzhou Xingrong Medical Technology...
General Hospital · 124d
Cleared Oct 05, 2021
Cala Trio
K203288 · QBC
Cala Health, Inc.
Neurology · 330d
Cleared Sep 30, 2021
Jada System
K212757 · OQY
Alydia Health
Obstetrics & Gynecology · 30d
Cleared Sep 30, 2021
Intravascular Administration Sets
K203609 · FPA
Baxter Healthcare Corporation
General Hospital · 294d
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