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"
1633–1656 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 21, 2015
SmartGownTM surgical gown
K150151 · FYA
Cardinal Health 200, Inc.
General Hospital · 118d
Cleared May 21, 2015
Intelli-Ox
K143060 · ECX
Air Liquide Healthcare
Anesthesiology · 209d
Cleared May 08, 2015
Jumong Series
K150816 · KPR
Sg Healthcare Co, Ltd.
Radiology · 42d
Cleared May 08, 2015
Touch Ultrasound
K150342 · IYO
Carestream Health, Inc.
Radiology · 86d
Cleared May 01, 2015
ADVIA Centaur TSH3-Ultra
K150403 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 72d
Cleared May 01, 2015
MERITS TRANSFORMER POWER SCOOTER, S941
K142162 · INI
Merits Health Products Co., Ltd.
Physical Medicine · 268d
Cleared Apr 29, 2015
Cardinal Health External Fixation System
K150579 · KTT
Cardinalhealth
Orthopedic · 51d
Cleared Apr 29, 2015
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K141984 · DXN
Andon Health Co, Ltd.
Cardiovascular · 282d
Cleared Apr 22, 2015
ADVIA CENTAUR TSH
K141999 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 273d
Cleared Apr 20, 2015
Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health...
K143016 · OMP
Cardinalhealth
General & Plastic Surgery · 182d
Cleared Apr 17, 2015
Exam Vue DR
K142930 · KPR
Jpi Healthcare Co, Ltd.
Radiology · 190d
Cleared Apr 16, 2015
Nitroglycerin Sets with DUO-VENT Spike
K150860 · FPA
Baxter Healthcare Corporation
General Hospital · 15d
Cleared Apr 13, 2015
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
K150132 · JJX
Siemens Healthcare Diagnostics
Chemistry · 82d
Cleared Apr 10, 2015
HEALTH KIOSK
K140360 · DXN
Engagementhealth, LLC
Cardiovascular · 422d
Cleared Apr 03, 2015
KIMGUARD ONE-STEP Sterilization Wrap
K143053 · FRG
Kimberly-Clark Health Care
General Hospital · 162d
Cleared Apr 02, 2015
MYGAIT STIMULATION SYSTEM
K141812 · GZI
Otto Bock Healthcare Products GmbH
Neurology · 269d
Cleared Mar 31, 2015
ADVIA Centaur Cortisol (COR) Assy
K142723 · JFT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 189d
Cleared Mar 27, 2015
HealthGuard-15
K143108 · DXN
Futrex, Inc.
Cardiovascular · 149d
Cleared Mar 26, 2015
Mammo Workstation
K143361 · LLZ
Ge Healthcare
Radiology · 122d
Cleared Mar 26, 2015
AVANCE FOAM DRESSING KITS
K141847 · OMP
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 260d
Cleared Mar 24, 2015
Customer Remote Console (CRC)
K150193 · LLZ
Ge Medical Systems, LLC
Radiology · 55d
Cleared Mar 24, 2015
Fluidshield* Surgical Mask with Expanded Chamber
K143287 · FXX
Halyard Health, Inc.
General Hospital · 127d
Cleared Mar 24, 2015
MiniStim MS-IVB Peripheral Nerve Stimulator
K143095 · BXN
Halyard Health, Inc.
Anesthesiology · 147d
Cleared Mar 23, 2015
BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES
K140477 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 390d