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

Filters: Cleared only ×
176,076 results
64297–64320 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 2005
EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
K050398 · LZO
Exactech, Inc.
Orthopedic · 275d
Cleared Nov 18, 2005
ACETYLCHOLINE RECEPTOR AB (ARAB)RRA
K051144 · NST
Ibl-Hamburg GmbH
Immunology · 198d
Cleared Nov 18, 2005
MEDITECH MODEL ABPM-04
K051149 · DXN
Meditech Kft.
Cardiovascular · 198d
Cleared Nov 18, 2005
QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
K051211 · NWM
Seradyn, Inc.
Chemistry · 191d
Cleared Nov 18, 2005
UVBIOTEK MODELS 3200B AND 4000B
K051330 · FTC
Medtek Lighting Corporation
General & Plastic Surgery · 182d
Cleared Nov 18, 2005
IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS
K051578 · DIO
Immunalysis Corporation
Toxicology · 157d
Cleared Nov 18, 2005
MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES
K051620 · FIP
Better Water, Inc.
Gastroenterology & Urology · 154d
Cleared Nov 18, 2005
JBAIDS ANTHRAC DETECTION SYSTEM
K051713 · NHT
Idaho Technology, Inc.
Microbiology · 144d
Cleared Nov 18, 2005
TRICOS T
K051722 · MQV
Baxter Healthcare Corp
Orthopedic · 144d
Cleared Nov 18, 2005
BETACONE HIP PROSTHESIS SYSTEM
K051826 · LWJ
Waldemar Link GmbH & Co. KG
Orthopedic · 136d
Cleared Nov 18, 2005
VINTAGE ZR
K052033 · EIH
Shofu Dental Corp.
Dental · 114d
Cleared Nov 18, 2005
NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES
K052502 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 66d
Cleared Nov 18, 2005
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA
K052530 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 65d
Cleared Nov 18, 2005
CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3
K052679 · JJX
Cliniqa Corporation
Chemistry · 51d
Cleared Nov 18, 2005
VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS)
K052851 · HAW
Mako Surgical Corp.
Neurology · 38d
Cleared Nov 18, 2005
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER
K052905 · GKZ
Beckman Coulter, Inc.
Hematology · 35d
Cleared Nov 18, 2005
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT...
K052961 · DRG
Philips Medical Systems
Cardiovascular · 28d
Cleared Nov 18, 2005
ENCOMPASS SOFTWARE PACKAGE
K053043 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 21d
Cleared Nov 18, 2005
RUBICOR MAGIC BREAST BIOPSY DEVICE
K053151 · KNW
Rubicor Medical, Inc.
Gastroenterology & Urology · 8d
Cleared Nov 17, 2005
GLAID OCULAR ELECTROPHYSIOLOGY DEVICE
K043367 · GWE
Lace Electronica S.R.L.
Neurology · 344d
Cleared Nov 17, 2005
ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS
K050024 · DIS
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 316d
Cleared Nov 17, 2005
SENTINEL UIBC LIQUID
K051111 · JQF
Sentinel Ch. Srl
Chemistry · 199d
Cleared Nov 17, 2005
AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER
K051226 · BZD
Cardinalhealth
Anesthesiology · 189d
Cleared Nov 17, 2005
CADD-MS 3 AMBULATORY INFUSION PUMP
K051568 · FRN
Smiths Medical MD, Inc.
General Hospital · 156d