FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68449–68472 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 2004
CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL...
K033919 · LPL
Ciba Vision Corporation
Ophthalmic · 85d
Cleared Mar 12, 2004
STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
K033944 · LZO
Stelkast Company
Orthopedic · 84d
Cleared Mar 12, 2004
STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM
K040022 · HRS
Stryker Leibinger
Orthopedic · 65d
Cleared Mar 12, 2004
IMMUNICON CELLTRACKS AUTOPREP SYSTEM
K040077 · GKH
Immunicon Corp.
Hematology · 58d
Cleared Mar 12, 2004
TRIMED BEARING PLATE
K040112 · HRS
Tri-Med, Inc.
Orthopedic · 52d
Cleared Mar 12, 2004
APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS
K040295 · HET
Applied Medical Resources Corp.
Obstetrics & Gynecology · 32d
Cleared Mar 12, 2004
SINON POWER WHEELCHAIR, SN-P401
K040320 · ITI
Sinon Corporation
Physical Medicine · 32d
Cleared Mar 12, 2004
MODIFICATION TO ORIA TOP CLIP SYSTEM
K040346 · MNI
Ortho Tec, LLC
Orthopedic · 29d
Cleared Mar 12, 2004
RANDOX LIQUID CRP CONTROLS
K040351 · JJX
Randox Laboratories, Ltd.
Chemistry · 29d
Cleared Mar 12, 2004
EMU128S, MODEL EX-NW-128S
K040360 · GWQ
Excel Tech. , Ltd.
Neurology · 28d
Cleared Mar 12, 2004
TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
K040447 · LQC
Boston Scientific Corp
Gastroenterology & Urology · 21d
Cleared Mar 11, 2004
POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX
K033177 · HET
Gunter Bissinger Medizintechnik GmbH
Obstetrics & Gynecology · 162d
Cleared Mar 11, 2004
GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE
K033351 · HRY
Global Orthopaedic Technology, USA, Inc.
Orthopedic · 143d
Cleared Mar 11, 2004
NAVIPRO KNEE SOFTWARE MODULE
K033668 · HAW
Kinamed, Inc.
Neurology · 111d
Cleared Mar 11, 2004
KAEN YIH UMBILICAL CORD CLAMP
K033846 · HFW
Kaen Yih Enterprise Co., Ltd.
Obstetrics & Gynecology · 91d
Cleared Mar 11, 2004
DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323,...
K033876 · DQA
Dolphin Medical, Inc.
Anesthesiology · 87d
Cleared Mar 11, 2004
PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032
K033894 · DXN
Matsushita Electric Works, Ltd.
Cardiovascular · 86d
Cleared Mar 11, 2004
PROGREAT
K033913 · KRA
Terumo Medical Corp.
Cardiovascular · 85d
Cleared Mar 11, 2004
ATH FEMORAL STEM
K034028 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 73d
Cleared Mar 11, 2004
FREELITE HUMAN KAPPA AND LAMBDA KITS
K040009 · DFH
The Binding Site, Ltd.
Immunology · 69d
Cleared Mar 11, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE
K040106 · LON
Becton, Dickinson & CO
Microbiology · 51d
Cleared Mar 11, 2004
PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS
K040280 · JJY
Roche Diagnostics Corp.
Chemistry · 34d
Cleared Mar 11, 2004
EL-ANA PROFILES: ANTI-CHROMATIN
K040291 · LJM
Theratest Laboratories, Inc.
Immunology · 34d
Cleared Mar 11, 2004
FLIGHT SOCK
K040353 · DWL
Ssl Americas, Inc.
General Hospital · 28d