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
64657–64680 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 2005
VITALCAREGIVING SYSTEM
K051544 · DXH
Advanced Monitoring Caregiving, Inc.
Cardiovascular · 119d
Cleared Oct 07, 2005
NOVASPINE CEMENT RESTRICTOR NSCR
K051607 · JDK
Novaspine, LLC
Orthopedic · 112d
Cleared Oct 07, 2005
ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
K051646 · JGS
Pointe Scientific, Inc.,
Chemistry · 108d
Cleared Oct 07, 2005
OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
K051742 · MQE
Inntec, Inc.
Obstetrics & Gynecology · 101d
Cleared Oct 07, 2005
EQUATOR PLUS ACETABULAR CUP SYSTEM
K051844 · MAY
Portland Orthopaedics Pty. , Ltd.
Orthopedic · 92d
Cleared Oct 07, 2005
NEOBLUE COZY LED PHOTOTHERAPY SYSTEM
K051869 · LBI
Natus Medical, Inc.
General Hospital · 88d
Cleared Oct 07, 2005
INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321
K051950 · MND
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 81d
Cleared Oct 07, 2005
SORING GMBH SONOCA LIPO
K052183 · QPB
Soring GmbH Medizintechnik
General & Plastic Surgery · 58d
Cleared Oct 07, 2005
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
K052261 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 49d
Cleared Oct 07, 2005
WIDE 5MP (MAMMO) LCD MONITOR SYSTEM
K052312 · LLZ
Wide Corporation
Radiology · 44d
Cleared Oct 07, 2005
AJEX 9015/135H PORTABLE X-RAY
K052341 · IZL
Jpi America, Inc.
Radiology · 42d
Cleared Oct 07, 2005
PROASIA, MODEL L3402
K052378 · INI
Proasia Limited
Physical Medicine · 38d
Cleared Oct 07, 2005
LANX VBR SYSTEM
K052384 · MQP
Lanx, LLC
Orthopedic · 38d
Cleared Oct 07, 2005
SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION
K052390 · HRS
Synthes (Usa)
Orthopedic · 37d
Cleared Oct 07, 2005
PROASIA, MODEL L4501
K052486 · INI
Proasia Limited
Physical Medicine · 28d
Cleared Oct 07, 2005
AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR
K052491 · MBI
Axya Medical, Inc.
Orthopedic · 25d
Cleared Oct 07, 2005
S-BONE HIP TOOL
K052538 · HRS
Orthopedic Sciences, Inc.
Orthopedic · 22d
Cleared Oct 07, 2005
1.5T 12 CHANNEL BODY ARRAY
K052584 · MOS
Usa Instruments, Inc.
Radiology · 17d
Cleared Oct 07, 2005
1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
K052621 · MOS
Usa Instruments, Inc.
Radiology · 14d
Cleared Oct 07, 2005
GEMINI RAPTOR
K052640 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 11d
Cleared Oct 07, 2005
ANTHOLOGY HIP STEM
K052792 · JDI
Smith & Nephew, Inc.
Orthopedic · 4d
Cleared Oct 06, 2005
KOWA VX-10
K043213 · HKI
Kowa Co. , Ltd.
Ophthalmic · 321d
Cleared Oct 06, 2005
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY
K051584 · MSD
Kendall
Gastroenterology & Urology · 113d
Cleared Oct 06, 2005
FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
K051987 · LYY
Pt. Mandiri Inti Buana
General Hospital · 76d