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
66721–66744 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 2005
SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS
K050077 · CIC
Arkray, Inc.
Chemistry · 34d
Cleared Feb 15, 2005
NEURO II-S
K050132 · LNH
Innovative Magnetic Resonance Imaging...
Radiology · 25d
Cleared Feb 15, 2005
WAVELIGHT SINON
K050218 · GEX
Wavelight Laser Technologie AG
General & Plastic Surgery · 15d
Cleared Feb 15, 2005
MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM
K050240 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 13d
Cleared Feb 14, 2005
BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY...
K033862 · FGE
Bioteque Corp.
Gastroenterology & Urology · 430d
Cleared Feb 14, 2005
MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS
K042659 · NON
Medisiss
Gastroenterology & Urology · 139d
Cleared Feb 14, 2005
CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G
K042730 · LYC
Lifecorebiomedical
Dental · 136d
Cleared Feb 14, 2005
VISCUCAM C DIGITAL CAMERA
K043222 · HKI
Carl Zeiss Meditec, AG
Ophthalmic · 84d
Cleared Feb 14, 2005
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM
K043589 · JWY
Dade Microscan, Inc.
Microbiology · 48d
Cleared Feb 14, 2005
ALLUX
K050203 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 17d
Cleared Feb 11, 2005
MONARCH NASAL IMPLANT
K041690 · FZE
Hanson Medical, Inc.
General & Plastic Surgery · 234d
Cleared Feb 11, 2005
HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL...
K041940 · LZO
Howmedica Osteonics Corp.
Orthopedic · 207d
Cleared Feb 11, 2005
STRYKER SPINE AVS TL PEEK SPACER
K042571 · MQP
Stryker Spine
Orthopedic · 143d
Cleared Feb 11, 2005
VANGUARD SSK KNEE SYSTEM
K042757 · JWH
Biomet, Inc.
Orthopedic · 130d
Cleared Feb 11, 2005
MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR
K042834 · GCJ
Micromedics, Inc.
General & Plastic Surgery · 121d
Cleared Feb 11, 2005
CORAIL AMT HIP PROSTHESIS
K042992 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 102d
Cleared Feb 11, 2005
MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600
K043006 · CAW
Respironics, Inc.
Anesthesiology · 102d
Cleared Feb 11, 2005
EASYSPINE SYSTEM
K043094 · MNI
Ldr Spine USA
Orthopedic · 94d
Cleared Feb 11, 2005
DEVILBISS AUTOADJUST, MODEL 9054 SERIES
K043282 · BZD
Sunrise Medical
Anesthesiology · 77d
Cleared Feb 11, 2005
E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT
K043289 · KTT
Signal Medical Corp.
Orthopedic · 74d
Cleared Feb 11, 2005
ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES
K043325 · EIA
Rolence Enteprise, Inc.
Dental · 71d
Cleared Feb 11, 2005
INF 4160, MODEL D-FJ27F
K043407 · LIH
Fuji Dynamics Limited
Neurology · 63d
Cleared Feb 11, 2005
QUICKIE INTERCHANGE FWD W/LIFT POWER WHEELCHAIR
K043435 · ITI
Sunrise Medical
Physical Medicine · 60d
Cleared Feb 11, 2005
ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS
K043463 · DQA
Envitec-Wismar GmbH
Anesthesiology · 58d