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

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176,076 results
60673–60696 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 2007
SPI ELEMENT PLATFORM O 4.0 MM
K070007 · DZE
Thommen Medical AG
Dental · 7d
Cleared Jan 09, 2007
ALEXIS WOUND RETRACTOR
K062907 · KGW
Applied Medical Resources
General & Plastic Surgery · 104d
Cleared Jan 09, 2007
HUMAPEN LUXURA HD
K063151 · NSC
Eli Lilly and Co.
General Hospital · 85d
Cleared Jan 09, 2007
SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM
K063456 · JAD
Topex, Inc.
Radiology · 55d
Cleared Jan 09, 2007
XODUS MEDICAL ANTI-FOG SOLUTION
K063587 · OCT
Xodus Medical, Inc.
Gastroenterology & Urology · 39d
Cleared Jan 08, 2007
POWERTONE, MODEL PT-11
K062439 · NGX
Johari Digital Healthcare , Ltd.
Physical Medicine · 140d
Cleared Jan 08, 2007
SIMPLEX P BONE CEMENT
K062553 · LOD
Stryker Orthopaedics
Orthopedic · 131d
Cleared Jan 08, 2007
TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1,...
K062937 · GXI
Baylis Medical Co., Inc.
Neurology · 102d
Cleared Jan 08, 2007
AG-EDGE, MODEL 91200
K063103 · CAF
Medel S.P.A.
Anesthesiology · 90d
Cleared Jan 08, 2007
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
K063405 · NCX
Radiant Medical
Neurology · 60d
Cleared Jan 08, 2007
ENCORE KNEE SYSTEM IFU
K063406 · JWH
Encore Medical, L.P.
Orthopedic · 60d
Cleared Jan 05, 2007
MODIFICATION TO: SATELLITE SPINAL SYSTEM
K060415 · NVR
Medtronic Sofamor Danek
Orthopedic · 322d
Cleared Jan 05, 2007
VITROS CHEMISTRY PRODUCTS BARB REAGENT
K062165 · DIS
Ortho-Clinical Diagnostics
Chemistry · 161d
Cleared Jan 05, 2007
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905
K062627 · DQO
Vascular Solutions, Inc.
Cardiovascular · 122d
Cleared Jan 05, 2007
CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE
K062780 · MEG
Medical Device Manufacturer...
General Hospital · 109d
Cleared Jan 05, 2007
SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
K063181 · NEI
Synthes (Usa)
Dental · 78d
Cleared Jan 05, 2007
AYCAN WORKSTATION OSIRIX
K063470 · LLZ
Aycan Digitalsysteme GmbH
Radiology · 50d
Cleared Jan 05, 2007
DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300...
K063525 · DSP
Datascope Corp.
Cardiovascular · 44d
Cleared Jan 05, 2007
PENCURE, MODEL VL-7
K063529 · EBZ
J. Morita USA, Inc.
Dental · 44d
Cleared Jan 05, 2007
HILGER DUAL-STIM NERVE STIMULATOR
K063560 · ETN
Wr Medical Electronics Co.
Ear, Nose, Throat · 38d
Cleared Jan 05, 2007
X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER
K063632 · LJE
C.R. Bard, Inc.
Gastroenterology & Urology · 30d
Cleared Jan 05, 2007
FUSION QUATTRO EXTRACTION BALLOON XL
K063677 · GCA
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 25d
Cleared Jan 05, 2007
SFB AND CFB IMPLANTS - 5.0 PLATFORM
K063718 · DZE
Nobel Biocare AB
Dental · 22d
Cleared Jan 05, 2007
SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
K063762 · JAK
Siemens AG Medical Solutions
Radiology · 16d