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"
2689–2712 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Jul 26, 2006
SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS
K061285 · FPA
Cardinal Health, Alaris Products
General Hospital · 79d
Cleared Jul 24, 2006
MERITS HEALTH PRODUCTS PORTABLE NEBULIZER
K053490 · CAF
Merits Health Products Co., Ltd.
Anesthesiology · 221d
Cleared Jul 12, 2006
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS
K061859 · MSH
Inovel, LLC
General Hospital · 12d
Cleared Jul 06, 2006
BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
K061139 · JIT
Bayer Healthcare, LLC
Immunology · 73d
Cleared Jul 06, 2006
ADVIA IMS CPSA CONTROL
K061137 · JJY
Bayer Healthcare, LLC
Immunology · 73d
Cleared Jun 26, 2006
AUTOBONE2
K061625 · JAK
Ge Healthcare
Radiology · 14d
Cleared Jun 26, 2006
RANGER IRRIGATION FLUID WARMING SYSTEM
K060939 · LGZ
Arizant Healthcare, Inc.
General Hospital · 81d
Cleared Jun 23, 2006
FULLCARD ANALYSIS
K061587 · KPS
Ge Healthcare
Radiology · 15d
Cleared Jun 23, 2006
PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING
K060509 · NYU
Tyco Healthcare Group
Gastroenterology & Urology · 116d