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
60961–60984 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 2006
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
K063045 · LEH
Diagnostic Products Corp.
Toxicology · 62d
Cleared Dec 05, 2006
DEMETRON A.2
K063116 · EBZ
Sybron Dental Specialties
Dental · 54d
Cleared Dec 05, 2006
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT...
K063213 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 43d
Cleared Dec 05, 2006
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)
K063313 · NTE
Boston Scientific Corp
Cardiovascular · 33d
Cleared Dec 05, 2006
ESA LEADCARE II LEAD CONTROL
K063398 · DIF
Bionostics, Inc.
Toxicology · 26d
Cleared Dec 05, 2006
TRUEHD (1080P) DIGITAL CAMERA SYSTEM
K063457 · GCJ
Conmed Linvatec
General & Plastic Surgery · 20d
Cleared Dec 04, 2006
INTIMOL
K061466 · NUC
Dlc Laboratories, Inc.
Obstetrics & Gynecology · 192d
Cleared Dec 04, 2006
LSC, MODEL 3
K061726 · IPL
Lifestand
Physical Medicine · 168d
Cleared Dec 04, 2006
EDIA ANTI-CCP
K062045 · NHX
Euro-Diagnostica AB
Immunology · 138d
Cleared Dec 04, 2006
PREVIEW ANTERIOR CERVICAL PLATE SYSTEM
K062371 · KWQ
Alphaspine, Inc.
Orthopedic · 112d
Cleared Dec 04, 2006
CELERITY
K062518 · EBF
Parkell, Inc.
Dental · 98d
Cleared Dec 04, 2006
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS...
K062750 · MUM
Boston Scientific Corp
Gastroenterology & Urology · 81d
Cleared Dec 04, 2006
PRESSUREWIRE CERTUS, MODELS 12006 AND 12306
K062769 · DXO
Radi Medical Systems AB
Cardiovascular · 80d
Cleared Dec 04, 2006
BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K062819 · GXN
Bioplate, Inc.
Neurology · 75d
Cleared Dec 04, 2006
TWIST DRILL
K062842 · HBE
Walter Lorenz Surgical, Inc.
Neurology · 73d
Cleared Dec 04, 2006
COMFORT SCOOTER MODEL LY-EW406
K063030 · INI
Comfort Orthopedic Co., Ltd.
Physical Medicine · 62d
Cleared Dec 04, 2006
TUFFLEX POLYESTER SUTURE
K063194 · GAT
Axya Medical, Inc.
General & Plastic Surgery · 45d
Cleared Dec 04, 2006
21.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2)
K063199 · LLZ
Totoku Electric Co., Ltd.
Radiology · 45d
Cleared Dec 04, 2006
ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200
K063308 · LYA
Carbylan Biosurgery
Ear, Nose, Throat · 32d
Cleared Dec 04, 2006
MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )
K063419 · MWI
Welch Allyn Protocol, Inc.
Cardiovascular · 21d
Cleared Dec 01, 2006
ILLUMIMED
K060792 · ILY
Photoactif, LLC
Physical Medicine · 253d
Cleared Dec 01, 2006
SPIROBANK II
K061712 · BZG
Mir Medical Intl. Research Srl
Anesthesiology · 165d
Cleared Dec 01, 2006
COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
K061937 · KNQ
Cook Endoscopy
Gastroenterology & Urology · 144d
Cleared Dec 01, 2006
NCONTACT COAGULATION SYSTEM KIT
K062539 · GEI
Ncontact Surgical, Inc.
General & Plastic Surgery · 94d