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"
2569–2592 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 28, 2007
ALARIS SYSTEM WITH MMS, MODEL 8XXX
K072105 · FRN
Cardinal Health 303,Inc.
General Hospital · 150d
Cleared Dec 21, 2007
GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
K062580 · GXY
Ge Healthcare
Neurology · 477d
Cleared Dec 20, 2007
MODEL 250CX SERIES MATERNAL/FETAL MONITOR
K072976 · HGM
Ge Healthcare
Obstetrics & Gynecology · 56d
Cleared Dec 19, 2007
OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412
K072168 · NGX
Well-Life Healthcare Limited
Physical Medicine · 135d
Cleared Dec 14, 2007
SMARTSITE STOPCOCK
K071400 · FMG
Cardinal Health, Alaris Products
General Hospital · 207d
Cleared Dec 13, 2007
DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE...
K071746 · KGO
Ansell Healthcare Products, LLC
General Hospital · 169d
Cleared Dec 07, 2007
ADVIA CHEMISTRY TOTAL BILIRUBIN_2
K063845 · JFM
Bayer Healthcare, LLC
Chemistry · 345d
Cleared Dec 05, 2007
ORTHOGON
K073271 · LLZ
Agfa Healthcare Corporation
Radiology · 14d
Cleared Nov 21, 2007
MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE
K073122 · FMI
Covidien Lp, Formerly Registered AS...
General Hospital · 15d
Cleared Nov 21, 2007
AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER
K071406 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 184d
Cleared Nov 20, 2007
INTEGRADWEB PACS SYSTEM
K072986 · LLZ
Ge Healthcare
Radiology · 28d
Cleared Nov 20, 2007
AVAFLEX VERTEBRAL AUGMENTATION NEEDLE
K072133 · NDN
Cardinal Health, Inc.
Orthopedic · 110d
Cleared Nov 19, 2007
COPA AMD ANTIMICROBIAL WOUND DRESSING
K071371 · FRO
Tyco Healthcare Group LP
General & Plastic Surgery · 187d
Cleared Nov 15, 2007
A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE
K072593 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 62d
Cleared Nov 15, 2007
BIOXTRA MOISTURIZING GEL
K072306 · LFD
Bio-X Healthcare S.A.
Dental · 90d
Cleared Nov 09, 2007
ACCESSA CHOLESTEROL PANEL
K063852 · JKA
Home Access Health Corp.
Chemistry · 316d
Cleared Nov 06, 2007
CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH...
K072576 · FPA
Baxter Healthcare Corp
General Hospital · 54d
Cleared Oct 25, 2007
DRYSTAR AXYS, MODEL EYZ4E
K072680 · LMC
Agfa Healthcare Corporation
Radiology · 31d
Cleared Oct 16, 2007
DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
K071049 · EZL
Tyco Healthcare
Gastroenterology & Urology · 186d
Cleared Oct 15, 2007
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
K063788 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 298d
Cleared Oct 10, 2007
MASTERSCREEN & OXYCON CPX
K072323 · BZC
Viasys Healthcare GmbH
Anesthesiology · 51d
Cleared Oct 10, 2007
NAVIGATOR APPLICATIONS SUITE
K071097 · BSZ
GE Healthcare Finland Oy
Anesthesiology · 175d
Cleared Oct 02, 2007
REPROCESSED TROCARS
K070059 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 270d
Cleared Sep 28, 2007
AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
K071920 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 78d