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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
73849–73872 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K023301 · LON
Becton, Dickinson & CO
Microbiology · 40d
Cleared Nov 12, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML
K023444 · LON
Becton, Dickinson & CO
Microbiology · 28d
Cleared Nov 12, 2002
ESSEX ENDOSCOPE, MODEL SXD-1000
K023627 · GCJ
Guidant Corp.
General & Plastic Surgery · 15d
Cleared Nov 12, 2002
ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200
K023629 · GCJ
Guidant Corporation, Cardiac Surgery
General & Plastic Surgery · 15d
Cleared Nov 08, 2002
BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER...
K011471 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 543d
Cleared Nov 08, 2002
PHILIPS M5066A AND M5068A
K020715 · MKJ
Philips Medical Systems
Cardiovascular · 248d
Cleared Nov 08, 2002
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M
K021239 · DXN
Eikon Healthcare Device Corp.
Cardiovascular · 204d
Cleared Nov 08, 2002
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200
K021240 · DXN
Eikon Healthcare Device Corp.
Cardiovascular · 204d
Cleared Nov 08, 2002
PNEUMOPERITONEUM INSUFFLATION NEEDLE
K021247 · HIF
Mectra Labs, Inc.
Obstetrics & Gynecology · 203d
Cleared Nov 08, 2002
PRECLUDE MVP DURA SUBSTITUTE
K021477 · GXQ
W.L. Gore & Associates, Inc.
Neurology · 184d
Cleared Nov 08, 2002
SUNPEX TECHNOLOGIES MODEL SE 01
K021925 · INI
Sunpex Technology Co., Ltd.
Physical Medicine · 150d
Cleared Nov 08, 2002
STRYKER POWERED WHEELED STRETCHER
K022309 · INK
Stryker Corp.
Physical Medicine · 115d
Cleared Nov 08, 2002
NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES
K022572 · LZA
Ar Alliance Healthcare Sdn. Bhd.
General Hospital · 98d
Cleared Nov 08, 2002
COLUMBUS TOTAL KNEE SYSTEM (CR)
K022672 · JWH
Aesculap, Inc.
Orthopedic · 88d
Cleared Nov 08, 2002
PRIMAGARD SURGICAL EQUIPMENT DRAPES
K022868 · KKX
Primeline Medical Products, Inc.
General Hospital · 71d
Cleared Nov 08, 2002
PRIMAGARD SURGICAL GOWNS
K023117 · KKX
Primeline Medical Products, Inc.
General Hospital · 58d
Cleared Nov 08, 2002
SPERM CRYOPROTEC
K023206 · MQL
Nidacon International AB
Obstetrics & Gynecology · 44d
Cleared Nov 08, 2002
PRIMAGARD SURGICAL GOWNS
K023266 · FYA
Primeline Medical Products, Inc.
General Hospital · 39d
Cleared Nov 08, 2002
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
K023398 · KGI
Hologic, Inc.
Radiology · 30d
Cleared Nov 08, 2002
HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
K023409 · LPH
Biomet, Inc.
Orthopedic · 29d
Cleared Nov 08, 2002
MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM
K023413 · GEI
Neothermia Corp.
General & Plastic Surgery · 28d
Cleared Nov 08, 2002
MODIFICATION TO VKS KNEE SYSTEM
K023416 · JWH
Plus Orthopedics
Orthopedic · 28d
Cleared Nov 08, 2002
MODIFICATION TO GELBFISH VASCULAR DILATORS
K023507 · DRE
Vascumetrix, LLC
Cardiovascular · 21d
Cleared Nov 08, 2002
ECAT LSO PET/CT 16
K023518 · KPS
Cti Pet Systems, Inc.
Radiology · 18d