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"
2617–2640 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 06, 2008
MERITS E600 SERIES STAIR LIFT
K073110 · ILK
Merits Health Products Co., Ltd.
Physical Medicine · 93d
Cleared Feb 05, 2008
MODIFICATION TO:HEALTH BUDDY APPLIANCE
K080091 · DRG
Health Hero Network, Inc.
Cardiovascular · 22d
Cleared Jan 31, 2008
RESUSCITATION TIMER, MODEL L770-CPR
K073171 · BTM
Allied Healthcare Products, Inc.
Anesthesiology · 83d
Cleared Jan 25, 2008
MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM
K073625 · DPS
Ge Healthcare Systems Information...
Cardiovascular · 30d
Cleared Jan 25, 2008
SAFESTEP MAX POWER-INJECTABLE INFUSION SET
K073050 · FPA
Specialized Health Products...
General Hospital · 88d
Cleared Jan 17, 2008
REGISTRATION AND FUSION
K080013 · LLZ
Agfa Healthcare Corporation
Radiology · 14d
Cleared Jan 14, 2008
MERITS E700 PORCE LIFT
K073513 · ING
Merits Health Products Co., Ltd.
Physical Medicine · 31d
Cleared Jan 14, 2008
START JUNIOR
K073512 · IOR
Otto Bock Healthcare LP
Physical Medicine · 31d
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