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"
2737–2760 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 23, 2006
AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
K062850 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 28d
Cleared Oct 19, 2006
XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210
K062079 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 90d
Cleared Oct 18, 2006
RESUSCITATION TIMER, MODEL L770-CPR
K062080 · BTM
Allied Healthcare Products, Inc.
Anesthesiology · 89d
Cleared Oct 13, 2006
MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300
K060669 · GZJ
Healthonics, Inc.
Neurology · 213d
Cleared Oct 11, 2006
MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K062663 · MSH
Moldex/Metric, Inc.
General Hospital · 34d
Cleared Oct 11, 2006
VANGUARD REPROCESSED SUTURE PASSER
K053585 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 292d
Cleared Oct 05, 2006
POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE
K062138 · LZA
Molnlycke Health Care, Inc.
General Hospital · 71d
Cleared Sep 29, 2006
DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM...
K062576 · MHX
Ge Healthcare
Cardiovascular · 29d
Cleared Sep 29, 2006
DLM112 DAYLINK MONITOR
K062304 · DRG
Rtx Healthcare A/S
Cardiovascular · 52d
Cleared Sep 29, 2006
TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233
K061942 · FLL
Ge Healthcare
General Hospital · 81d
Cleared Sep 21, 2006
INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
K062457 · MEB
Baxter Healthcare Corporation
General Hospital · 29d
Cleared Sep 15, 2006
MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM
K061741 · DQK
Ge Healthcare
Cardiovascular · 87d
Cleared Sep 11, 2006
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151
K062058 · NBW
Bayer Healthcare
Chemistry · 53d
Cleared Sep 11, 2006
RENALSOFT
K061515 · KPF
Baxter Healthcare Corp
Gastroenterology & Urology · 102d
Cleared Sep 05, 2006
REPROCESSED EXTERNAL FIXATION DEVICE
K061759 · KTT
Ascent Healthcare Solutions
Orthopedic · 75d
Cleared Sep 01, 2006
GE VANTAGE PET NEURO SOFTWARE
K062393 · KPS
Ge Healthcare
Radiology · 16d
Cleared Sep 01, 2006
AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE
K062326 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 23d
Cleared Aug 29, 2006
FLEXIFIT HC432 FULL FACE MASK
K061236 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 118d
Cleared Aug 18, 2006
FOLEY CATHETERS WITH TEMPERATURE PROBE
K061918 · EYC
Ge Healthcare
Gastroenterology & Urology · 43d
Cleared Aug 14, 2006
ARM BLOOD PRESSURE MONITOR, MODEL KP-7600
K061760 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 53d
Cleared Aug 11, 2006
WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE
K061994 · MSX
Ge Healthcare
Cardiovascular · 28d
Cleared Aug 03, 2006
MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE
K061492 · FMF
Tyco Healthcare
General Hospital · 64d
Cleared Aug 02, 2006
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3
K061822 · DXN
Omron Healthcare, Inc.
Cardiovascular · 35d
Cleared Aug 01, 2006
TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N
K061762 · KKX
Cardinal Health, Inc.
General Hospital · 40d