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
64249–64272 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 2005
SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM
K050209 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 299d
Cleared Nov 23, 2005
NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS
K050800 · FRN
Caesarea Medical Electronics , Ltd.
General Hospital · 238d
Cleared Nov 23, 2005
OMNIPICC PI
K051102 · LJS
Rita Medical Systems, Inc.
General Hospital · 208d
Cleared Nov 23, 2005
IGD DIAGNOSTIC TEST KITS
K051299 · CZJ
The Binding Site, Ltd.
Immunology · 189d
Cleared Nov 23, 2005
WIESLAB CAP MPO-ANCA
K051455 · MOB
Eurodiagnostica
Immunology · 174d
Cleared Nov 23, 2005
POWERPICC
K051672 · LJS
Bard Access Systems, Inc.
General Hospital · 153d
Cleared Nov 23, 2005
GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS...
K051734 · HAW
Ge Healthcare Technologies
Neurology · 148d
Cleared Nov 23, 2005
BE-CERTAIN PREGNANCY TEST
K051963 · LCX
Natureplex, LLC
Chemistry · 127d
Cleared Nov 23, 2005
CRONO FIVE AND CRONO PCA 50
K052218 · FRN
Cane S.R.L.
General Hospital · 100d
Cleared Nov 23, 2005
ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS
K052255 · LPH
Biomet, Inc.
Orthopedic · 97d
Cleared Nov 23, 2005
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER
K052257 · DQY
Vascular Solutions, Inc.
Cardiovascular · 97d
Cleared Nov 23, 2005
QUANTA LITE CCP3 IGG ELISA
K052264 · NHX
Inova Diagnostics, Inc.
Immunology · 96d
Cleared Nov 23, 2005
SUPER PORCELAIN EX-3 PRESS
K052304 · EIH
Noritake Co., Inc.
Dental · 91d
Cleared Nov 23, 2005
ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA
K052335 · BSZ
Accutron, Inc.
Anesthesiology · 89d
Cleared Nov 23, 2005
VISION (WITH OFF-LINE REVIEW)
K052391 · IYE
Varian Medical Systems
Radiology · 84d
Cleared Nov 23, 2005
IMPRESSIX
K052455 · ELW
Cavex Holland BV
Dental · 77d
Cleared Nov 23, 2005
TERUMO MICRO TAPERED PEN NEEDLE
K052561 · FMI
Kofu Factory of Terumo Corp.
General Hospital · 65d
Cleared Nov 23, 2005
ASSISTO ARM SYSTEMS
K052745 · GWG
Geomed Medizin-Technik GmbH & Co.
Neurology · 54d
Cleared Nov 23, 2005
MREYE EMBOLIZATION COIL
K052834 · KRD
Cook, Inc.
Cardiovascular · 48d
Cleared Nov 23, 2005
IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL...
K052872 · DXN
Taidoc Technology Corporation
Cardiovascular · 43d
Cleared Nov 23, 2005
SONOLINE G60 S ULTRASOUND SYSTEM
K052894 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 40d
Cleared Nov 23, 2005
THROMBIX 3X3 HEMOSTATIC PAD
K053054 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 23d
Cleared Nov 23, 2005
VIMPLANT
K053155 · LLZ
Cybermed, Inc.
Radiology · 9d
Cleared Nov 22, 2005
URYXXON 200 URINE ANALYZER
K051034 · JIL
Macherey-Nagel GmbH & Co. KG
Chemistry · 214d