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

5,279 results for "health"
1729–1752 of 5,279
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 06, 2015
IMPAX Agility
K142316 · LLZ
Agfa Healthcare N.V.
Radiology · 140d
Cleared Dec 24, 2014
IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000...
K143352 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 30d
Cleared Dec 23, 2014
ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur...
K143376 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 28d
Cleared Dec 19, 2014
Full Automatic (NIBP) Blood Pressure Monitor
K142968 · DXN
Health & Life Co., Ltd.
Cardiovascular · 66d
Cleared Dec 18, 2014
KIMGUARD ONE STEP STERILIZATION WRAP
K141712 · FRG
Halyard Health
General Hospital · 176d
Cleared Dec 12, 2014
YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
K141304 · LZA
Yongxin Healthcare Co., Ltd.
General Hospital · 207d
Cleared Dec 05, 2014
ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol...
K143194 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 29d
Cleared Dec 05, 2014
ADVIA Centaur HAV total assay
K142758 · LOL
Siemens Healthcare Diagnostics, Inc.
Microbiology · 71d
Cleared Dec 03, 2014
MAXPOWER RELIEF
K141978 · NUH
Omron Healthcare, Inc.
Neurology · 135d
Cleared Dec 02, 2014
Infrared Therapy System
K142340 · ILY
Beijing Huatai Healthcare Technology...
Physical Medicine · 103d
Cleared Dec 02, 2014
HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE
K141862 · NBW
H2, Inc.
Chemistry · 145d
Cleared Dec 01, 2014
BP652N (HEM-6300-Z)
K142917 · DXN
Omron Healthcare, Inc.
Cardiovascular · 55d
Cleared Nov 26, 2014
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA...
K140859 · CEC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 237d
Cleared Nov 26, 2014
DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI...
K140842 · CEC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 238d
Cleared Nov 21, 2014
LG SMARTHEALTH
K133997 · DRG
Lg Electronics
Cardiovascular · 329d
Cleared Nov 21, 2014
PHILIPS IQON SPECTRAL CT
K133674 · JAK
Philips Healthcare (Cleveland)
Radiology · 357d
Cleared Nov 19, 2014
VIAL-MATE Adaptor
K142600 · LHI
Baxter Healthcare Corporation
General Hospital · 65d
Cleared Nov 19, 2014
UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea...
K142510 · HQD
Synergeyes, Inc.
Ophthalmic · 72d
Cleared Nov 17, 2014
CLINITEK NOVUS
K140717 · KQO
Siemens Healthcare Diagnostics
Chemistry · 242d
Cleared Nov 14, 2014
OTC COMBO TENS/EMS SYSTEM
K141299 · NUH
Well-Life Healthcare Limited
Neurology · 179d
Cleared Nov 14, 2014
TECOTHERM NEO (T NEO)
K140078 · DWJ
Inspiration Healthcare, Ltd.
Cardiovascular · 305d
Cleared Nov 12, 2014
HEALTH EXPERT ELCTRONIC STIMULATOR
K133929 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 324d
Cleared Nov 10, 2014
LEAF PATIENT MONITORING SYSTEM
K141877 · KMI
Leaf Healthcare, Inc.
General Hospital · 122d
Cleared Oct 30, 2014
IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material,...
K142878 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d