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
64393–64416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 2005
USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY
K052916 · MOS
Usa Instruments, Inc.
Radiology · 23d
Cleared Nov 09, 2005
GE 1.5T SIGNA HDE MR SYSTEM
K052978 · LNH
Ge Medical Systems, LLC
Radiology · 16d
Cleared Nov 09, 2005
PARACEM UNIVERSAL DC
K053040 · EMA
Coltene/Whaledent AG
Dental · 13d
Cleared Nov 08, 2005
VERTEFIX VERTEBROPLASTY PROCEDURE SET
K042691 · NDN
Cook, Inc.
Orthopedic · 405d
Cleared Nov 08, 2005
MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)
K051082 · KMF
Medtrade Products , Ltd.
General & Plastic Surgery · 195d
Cleared Nov 08, 2005
FORTADERM ANTIMICROBIAL WOUND DRESSING
K051647 · FRO
Organogenesis, Inc.
General & Plastic Surgery · 140d
Cleared Nov 08, 2005
INFINITT G3 PACS
K052545 · LLZ
Infinitt Co., Ltd.
Radiology · 54d
Cleared Nov 08, 2005
CRC 15ULTRA
K052595 · JAQ
Capintec, Inc.
Radiology · 48d
Cleared Nov 08, 2005
MODIFICATION TO: AURORA
K052698 · LNH
Aurora Imaging Technology, Inc.
Radiology · 41d
Cleared Nov 08, 2005
POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE
K052709 · LYY
Pt.Shamrock Manufacturing Corp.
General Hospital · 40d
Cleared Nov 08, 2005
POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE
K052877 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 27d
Cleared Nov 08, 2005
GE DEFINIUM AMX 700, MODEL AMX 700
K052897 · IZL
General Electric Medical Systems
Radiology · 25d
Cleared Nov 08, 2005
BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI...
K052987 · LNH
Noras Rontgen-Und Medizintechnik GmbH
Radiology · 15d
Cleared Nov 08, 2005
ADVANTAGE WORKSTATION 4.3.
K052995 · LLZ
Ge Healthcare
Radiology · 14d
Cleared Nov 08, 2005
POLY SILOXANE IMPRESSION MATERIAL
K053018 · ELW
Millennium Dental International, Inc.
Dental · 13d
Cleared Nov 08, 2005
ILUMA ORTHOCAT/DENTALCAT
K053046 · JAK
Imtec Corp.
Radiology · 11d
Cleared Nov 07, 2005
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102
K043007 · JBQ
Hyphen Biomed
Hematology · 371d
Cleared Nov 07, 2005
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
K052280 · NFA
Boston Scientific Corp
Cardiovascular · 77d
Cleared Nov 07, 2005
UNI-THREAD SPINAL SYSTEM
K052406 · MNI
Spine Vision, Inc.
Orthopedic · 67d
Cleared Nov 07, 2005
MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE
K052437 · GAM
Surgical Specialties Corp
General & Plastic Surgery · 62d
Cleared Nov 07, 2005
SBI AUTOFIX
K052576 · HWC
Small Bone Innovations, LLC
Orthopedic · 49d
Cleared Nov 07, 2005
ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS,...
K052607 · HWC
Arthrex, Inc.
Orthopedic · 46d
Cleared Nov 07, 2005
ABBOTT SPINE, INC. SPINNAKER SYSTEM
K052638 · KNW
Abbott Spine, Inc.
Gastroenterology & Urology · 42d
Cleared Nov 07, 2005
VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN
K052656 · LON
bioMerieux, Inc.
Microbiology · 42d