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

5,281 results for "health"
2857–2880 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 03, 2005
ADVIA CHEMISTRY MICROALBUMIN CONTROLS
K052242 · JJW
Bayer Healthcare, LLC
Chemistry · 47d
Cleared Sep 20, 2005
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
K051873 · FLL
Ge Healthcare
General Hospital · 71d
Cleared Sep 16, 2005
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
K052412 · OWB
Ge Healthcare
Radiology · 14d
Cleared Sep 15, 2005
SCHUCO MIST AND SCHUCO DELUXE MIST
K051260 · CAF
Allied Healthcare Products, Inc.
Anesthesiology · 123d
Cleared Sep 14, 2005
ADVANTAGE SIM MD
K052345 · KPQ
Ge Healthcare
Radiology · 19d
Cleared Sep 12, 2005
PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W,...
K051565 · DXN
Proton Healthcare , Ltd.
Cardiovascular · 90d
Cleared Sep 09, 2005
VCS S3Y
K051130 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 129d
Cleared Sep 08, 2005
DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES
K052167 · CCK
Ge Healthcare
Anesthesiology · 30d
Cleared Sep 08, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC
K052154 · DXN
Omron Healthcare, Inc.
Cardiovascular · 30d
Cleared Sep 08, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL
K052153 · DXN
Omron Healthcare, Inc.
Cardiovascular · 30d
Cleared Aug 23, 2005
DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES
K052145 · OLW
Ge Healthcare
Neurology · 15d
Cleared Aug 22, 2005
RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE
K051947 · LFL
Radionics, A Division of Tyco...
General & Plastic Surgery · 35d
Cleared Aug 17, 2005
ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING...
K051793 · KGO
Ansell Healthcare Products, LLC
General Hospital · 47d
Cleared Aug 15, 2005
VCS S3T
K051131 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 104d
Cleared Aug 12, 2005
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121,...
K051370 · JOL
Baxter Healthcare Corp
General Hospital · 78d
Cleared Aug 09, 2005
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
K051967 · KPR
Ge Healthcare
Radiology · 20d
Cleared Aug 05, 2005
SPLASH! IMPRESSION MATERIAL DEVICE
K052090 · ELW
Discus Dental, Inc.
Dental · 3d
Cleared Aug 05, 2005
DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG...
K051883 · OLT
Ge Healthcare
Neurology · 24d
Cleared Aug 04, 2005
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR
K050430 · CAW
Merits Health Products Co., Ltd.
Anesthesiology · 167d
Cleared Aug 03, 2005
AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
K050994 · BZD
Cardinalhealth
Anesthesiology · 106d
Cleared Aug 01, 2005
LIPOPROTEIN FOR MULTIPLE ANALYTES
K051619 · JIX
Bayer Healthcare, LLC
Chemistry · 45d
Cleared Aug 01, 2005
RT019 INSPIRATORY/EXPIRATORY FILTER
K050927 · CAH
Fisher &Paykel Healthcare , Ltd.
General Hospital · 110d
Cleared Jul 22, 2005
COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321
K051365 · CAF
K-Jump Health Co., Ltd.
Anesthesiology · 58d
Cleared Jul 19, 2005
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION
K051634 · MSX
Ge Healthcare
Cardiovascular · 29d