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

5,280 results for "health"
2593–2616 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 11, 2008
PRECISION 500D R&F X-RAY SYSTEM
K081091 · JAA
Ge Healthcare
Radiology · 56d
Cleared May 28, 2008
UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE...
K080551 · JOW
University of Utah Hospitals and Clinics
Cardiovascular · 90d
Cleared May 28, 2008
HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862,...
K080424 · NLF
Hygia Health Services, Inc.
Anesthesiology · 103d
Cleared May 23, 2008
LOCI THYROID CALIBRATOR WITH MODEL RC610
K081103 · JIX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared May 23, 2008
DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF...
K081074 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d
Cleared May 23, 2008
CLEANSE.FRESHEN.GO
K080631 · EFT
Oral Health Technologies, LLC
Dental · 79d
Cleared May 19, 2008
MODIFICATION TO 3M TEGADERM CHG DRESSING
K080620 · FRO
3M Company-3M Health Care
General & Plastic Surgery · 76d
Cleared May 19, 2008
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE
K071889 · DSI
Ge Healthcare
Cardiovascular · 315d
Cleared May 16, 2008
DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT...
K080578 · NBC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 74d
Cleared May 09, 2008
GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)
K081105 · JAK
Ge Healthcare
Radiology · 21d
Cleared May 05, 2008
BRACHYTHERAPY SOURCE DEVICE, MODEL 9011
K081066 · IWG
Medi-Physics, Inc., Dba GE Healthcare
Radiology · 20d
Cleared May 05, 2008
AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH...
K080898 · GDW
Tyco Healthcare Group LP
General & Plastic Surgery · 35d
Cleared Apr 30, 2008
ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM
K080845 · JCX
Cardinalhealth
General & Plastic Surgery · 35d
Cleared Apr 22, 2008
MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY
K072061 · JEH
Viasys Healthcare GmbH
Anesthesiology · 270d
Cleared Apr 11, 2008
QHRV 1 - HEALTH ASSESSMENT SYSTEM
K080884 · DPS
Medtechs, LLC
Cardiovascular · 11d
Cleared Apr 10, 2008
TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL
K071524 · MQX
Tcm World, Inc.
General Hospital · 311d
Cleared Apr 08, 2008
TRICOS T RESORBABLE BONE SUBSTITUTE
K073571 · LYC
Baxter Healthcare Corporation
Dental · 110d
Cleared Mar 31, 2008
RESPIRATORY HUMIDIFIER, MODEL MR850
K073706 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 91d
Cleared Mar 27, 2008
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K061907 · OLW
Ge Healthcare
Neurology · 631d
Cleared Mar 11, 2008
KFH ENERGY, MODEL: E1
K073008 · GZJ
Kingfisher Healthcare NV
Neurology · 139d
Cleared Mar 06, 2008
PORTABLE VENTILATOR, MODEL EPV-100
K072214 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 210d
Cleared Mar 06, 2008
HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5
K072163 · CAF
3A Health Care S.R.L.
Anesthesiology · 213d
Cleared Mar 06, 2008
LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM
K070800 · MOL
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 349d
Cleared Feb 26, 2008
1500 PRO
K080289 · DXN
Omron Healthcare, Inc.
Cardiovascular · 22d