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

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175,820 results
123985–124008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 1990
PRECISION HIP STEM WITH ADDITIONAL STEM SIZES
K904844 · JDI
Howmedica Corp.
Orthopedic · 41d
Cleared Dec 05, 1990
EYE PAD
K904896 · HMP
Ulti-Med Intl., Inc.
General & Plastic Surgery · 36d
Cleared Dec 05, 1990
PROXIMAL FEMUR REPLACEMENT STEM
K904919 · JDI
Depuy, Inc.
Orthopedic · 35d
Cleared Dec 05, 1990
STERI-VAC(TM) AERATOR MODEL XL
K904921 · FLI
3M Health Care, Ltd.
General Hospital · 35d
Cleared Dec 05, 1990
DPX-L AND DPX-ALPHA, MODIFICATION
K904980 · KGI
Lunar
Radiology · 33d
Cleared Dec 04, 1990
NEURITOR 2001
K902752 · GWQ
Imexco General , Ltd.
Neurology · 165d
Cleared Dec 04, 1990
LATEX EXAMINATION GLOVES
K902796 · LYY
Ek Hong Rubber Industry (Thailand)...
General Hospital · 161d
Cleared Dec 04, 1990
TRANSTAT-CMV(TM)
K903308 · LFX
Ab Sangtec Medical
Microbiology · 133d
Cleared Dec 04, 1990
VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG
K903882 · GQW
Viral Antigens, Inc.
Microbiology · 104d
Cleared Dec 04, 1990
MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE
K903921 · IZZ
Imt America, Inc.
Radiology · 102d
Cleared Dec 04, 1990
RUBELLA IGM ELISA TEST
K904084 · LFX
Gull Laboratories, Inc.
Microbiology · 90d
Cleared Dec 04, 1990
COSPAN CONTINUOUS SPINAL ANESTHESIA TRAY
K904101 · CAZ
Kendall Healthcare Products Co....
Anesthesiology · 89d
Cleared Dec 04, 1990
SINGLE LUMEN CATHETER KITS
K904139 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 89d
Cleared Dec 04, 1990
FLEXISYS
K904149 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 88d
Cleared Dec 04, 1990
ICOR HCH 4, ICOR HCH 7
K904338 · BYD
Icor AB
Anesthesiology · 75d
Cleared Dec 04, 1990
IMPRAFLO 3500 SERIES
K904515 · CAC
Impra, Inc.
Anesthesiology · 62d
Cleared Dec 04, 1990
P AND T MEDIUM
K904773 · JTW
Gibson Laboratories, Inc.
Microbiology · 43d
Cleared Dec 04, 1990
RUBEOLA IGG ELISA TEST
K904854 · LJB
Gull Laboratories, Inc.
Microbiology · 36d
Cleared Dec 04, 1990
PROGRAMMABLE VIDEO CONTROLLER MODEL PK2060
K904986 · JAA
Perkins Mfg. Co.
Radiology · 32d
Cleared Dec 04, 1990
ORTHO RUBELLA-M ANTIBODY ELISA TEST
K905079 · LFX
Ortho Diagnostic Systems, Inc.
Microbiology · 21d
Cleared Dec 04, 1990
SPORTS RIDER AND SHOP RIDER
K905245 · INI
National Health Services, Inc.
Physical Medicine · 13d
Cleared Dec 03, 1990
KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM
K896437 · DPT
Kontron Instruments, Inc.
Cardiovascular · 389d
Cleared Dec 03, 1990
ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE
K900560 · DQC
Acuson Corp.
Cardiovascular · 299d
Cleared Dec 03, 1990
AMPLATZ GOOSE-NECK SNARE
K901502 · DXE
Microvena Corp.
Cardiovascular · 249d