Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
74449–74472 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 2002
SPI EASY DENTAL IMPLANT ABUTMENT
K023645 · NHA
Thommen Medical AG
Dental · 14d
Cleared Nov 13, 2002
EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM
K023646 · JDI
Exactech, Inc.
Orthopedic · 14d
Cleared Nov 12, 2002
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022178 · MOI
Bayer Diagnostics Corp.
Immunology · 132d
Cleared Nov 12, 2002
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC...
K022574 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 102d
Cleared Nov 12, 2002
KLARITY
K022708 · IYE
Larson Products, Inc.
Radiology · 90d
Cleared Nov 12, 2002
HAND DRILL, MODEL 11-9901-7
K022712 · HBG
Medical Design, LLC
Neurology · 90d
Cleared Nov 12, 2002
MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POEDER FREE
K023159 · LYY
Industrial Clothings, Ltd.
General Hospital · 50d
Cleared Nov 12, 2002
SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
K023236 · KGO
Maxxim Medical
General Hospital · 46d
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