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
65089–65112 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 2005
INCLOSE SURGICAL MESH SYSTEM
K050969 · FTL
Anulex Technologies, Inc.
General & Plastic Surgery · 122d
Cleared Aug 18, 2005
MICROPULSE PHACOEMULSIFICATION SYSTEM
K051186 · HQC
Trillium Medical, Inc.
Ophthalmic · 101d
Cleared Aug 18, 2005
CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL...
K051305 · PSW
Cs Medical, LLC
General Hospital · 91d
Cleared Aug 18, 2005
EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX
K051337 · OBJ
Volcano Corporation
Radiology · 87d
Cleared Aug 18, 2005
COLONIC AND ENEMA NOZZLE
K051344 · KPL
Ultimate Concepts, Inc.
Gastroenterology & Urology · 87d
Cleared Aug 18, 2005
INVADER UGT1A1 MOLECULAR ASSAY
K051824 · NTI
Third Wave Technologies, Inc.
Chemistry · 44d
Cleared Aug 18, 2005
MODIFICATION TO: XIA STAINLESS STEEL SYSTEM
K051973 · KWP
Stryker Spine
Orthopedic · 28d
Cleared Aug 18, 2005
DIOMED DELTA 15, MODEL DELTA 15
K051996 · GEX
Diomed, Ltd.
General & Plastic Surgery · 24d
Cleared Aug 18, 2005
MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM
K052166 · NTE
Guidant Corporation
Cardiovascular · 9d
Cleared Aug 17, 2005
VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT
K050644 · MMI
Vancouver Biotech , Ltd.
Chemistry · 156d
Cleared Aug 17, 2005
MEE-1000A NEUROMASTER
K051178 · GWF
Nihon Kohden America, Inc.
Neurology · 100d
Cleared Aug 17, 2005
SILBRONCHO DOUBLE LUMEN TUBE
K051522 · CBI
Fuji Systems Corp.
Anesthesiology · 70d
Cleared Aug 17, 2005
STRATUS CS D-DIMER
K051597 · DAP
Dade Behring, Inc.
Hematology · 62d
Cleared Aug 17, 2005
IQ BODY FLUIDS CONTROL
K051706 · JPK
Streck
Hematology · 51d
Cleared Aug 17, 2005
PENUMBRA ASPIRATION PUMP, MODEL 115V
K051758 · BTA
Penumbra, Inc.
General & Plastic Surgery · 49d
Cleared Aug 17, 2005
ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING...
K051793 · KGO
Ansell Healthcare Products, LLC
General Hospital · 47d
Cleared Aug 17, 2005
NIO 3MP-21
K051901 · LLZ
Barcoview
Radiology · 35d
Cleared Aug 17, 2005
RESOLVE OPEN BACK HALO RINGS
K051918 · HAX
Jerome Medical
Neurology · 33d
Cleared Aug 17, 2005
BIOVALVE MINI-JECT NEEDLEFREE INJECTOR
K051985 · KZE
Biovalve Technologies, Inc.
General Hospital · 26d
Cleared Aug 17, 2005
V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER
K052021 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Aug 17, 2005
PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES
K052069 · KWP
Globus Medical, Inc.
Orthopedic · 16d
Cleared Aug 17, 2005
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
K052111 · GXZ
Excel Tech. , Ltd.
Neurology · 13d
Cleared Aug 16, 2005
SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES
K050183 · CAF
Silvestrin Fabris S.R.L.
Anesthesiology · 201d
Cleared Aug 16, 2005
VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS
K050222 · MBH
Biomet, Inc.
Orthopedic · 197d