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
67465–67488 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 2004
CAPNOSTAT 5
K042601 · CCK
Respironics Novametrix, Inc.
Anesthesiology · 56d
Cleared Nov 19, 2004
NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K042660 · LLZ
Barco NV Barcoview
Radiology · 52d
Cleared Nov 19, 2004
NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K042661 · LLZ
Barco NV Barcoview
Radiology · 52d
Cleared Nov 19, 2004
PLANMED SOPHIE NUANCE CLASSIC
K042671 · IZH
Planmed OY
Radiology · 51d
Cleared Nov 19, 2004
RHIGENE HEP-ANA TEST SYSTEM
K042680 · DHN
Corgenix, Inc.
Immunology · 51d
Cleared Nov 19, 2004
SECOND LOOK VIEWER
K042697 · LLZ
Icad, Inc.
Radiology · 50d
Cleared Nov 19, 2004
ARCHITECT CA 125 II ASSAY
K042731 · LTK
Fujirebio Diagnostics,Inc.
Immunology · 49d
Cleared Nov 19, 2004
IMALUX NIRIS IMAGING SYSTEM
K042894 · NQQ
Imalux Corporation
General & Plastic Surgery · 30d
Cleared Nov 19, 2004
AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
K042897 · GAL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 30d
Cleared Nov 19, 2004
AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101
K042906 · FLL
Amplife Corporation
General Hospital · 29d
Cleared Nov 19, 2004
VENTURE ANTERIOR CERVICAL PLATING SYSTEM
K042922 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Nov 19, 2004
DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H
K042966 · MAI
Linvatec Biomaterials, Ltd.
Orthopedic · 22d
Cleared Nov 19, 2004
SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250
K043025 · KPR
Analogic Corp.
Radiology · 16d
Cleared Nov 19, 2004
3VISEON
K043097 · LLZ
3Mensio Medical Imaging BV
Radiology · 10d
Cleared Nov 18, 2004
IOP8 INTRA OPERATIVE PROBE
K032315 · ITX
Huntleigh Healthcare, Inc.
Radiology · 479d
Cleared Nov 18, 2004
SDS-4I
K034005 · IPF
Skylark Device & Systems Co., Ltd.
Physical Medicine · 330d
Cleared Nov 18, 2004
BASBA E-MACHINE
K041172 · GZJ
Basba, Inc.
Neurology · 198d
Cleared Nov 18, 2004
SELF RETAINING BICANALICULUS INTUBATION SET
K041869 · OKS
Fci Ophthalmics, Inc.
Ophthalmic · 132d
Cleared Nov 18, 2004
FUJINON G5 DUODENSCOPES
K042076 · FDT
Fujinon, Inc.
Gastroenterology & Urology · 108d
Cleared Nov 18, 2004
GRADIA DIRECT LOFLO
K042348 · EBF
GC America, Inc.
Dental · 80d
Cleared Nov 18, 2004
SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM
K042365 · JEY
Synthes (Usa)
Dental · 79d
Cleared Nov 18, 2004
VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22...
K042521 · JIT
Ortho-Clinical Diagnostics, Inc.
Chemistry · 63d
Cleared Nov 18, 2004
QUIKREAD CRP CALIBRATOR SET
K042625 · JJY
Orion Diagnostica, OY
Chemistry · 52d
Cleared Nov 18, 2004
VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE...
K042643 · DCF
Ortho-Clinical Diagnostics, Inc.
Chemistry · 52d