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
63001–63024 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 2006
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
K060990 · NKB
Endius, Inc.
Orthopedic · 16d
Cleared Apr 25, 2006
PHYSIOGLOVE ES
K050674 · DPS
Commwell , Ltd.
Cardiovascular · 406d
Cleared Apr 25, 2006
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003
K053263 · DSI
Cardionet, Inc.
Cardiovascular · 154d
Cleared Apr 25, 2006
LESIONPOINT RF CANNULA
K053415 · GXI
Cosman Medical, Inc.
Neurology · 139d
Cleared Apr 25, 2006
THROMCAT THROMBECTOMY CATHETER SYSTEM
K060016 · MCW
Kensey Nash Corp.
Cardiovascular · 112d
Cleared Apr 25, 2006
SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24
K060376 · DZE
Simpler Implant, Inc.
Dental · 70d
Cleared Apr 25, 2006
EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER
K060660 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 43d
Cleared Apr 25, 2006
NURSE ASSISTANT 1.7 O.R. CONTROL SYSTEM
K060717 · GCJ
Conmed Integrated Systems (Cmis)
General & Plastic Surgery · 39d
Cleared Apr 25, 2006
MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310
K060845 · LLZ
Eizo Nanao Corporation
Radiology · 28d
Cleared Apr 24, 2006
RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR...
K052520 · DJG
Tianjin New Bay Bioresearch Co., Ltd.
Chemistry · 222d
Cleared Apr 24, 2006
IVA (MXA II SOFTWARE OPTION)
K060111 · KGI
Hologic, Inc.
Radiology · 97d
Cleared Apr 24, 2006
CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250
K060140 · JIT
Diagnostic Chemicals , Ltd.
Chemistry · 95d
Cleared Apr 24, 2006
VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT
K060168 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 91d
Cleared Apr 24, 2006
GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE
K060195 · KDI
Gambro Renal Products
Gastroenterology & Urology · 89d
Cleared Apr 24, 2006
NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE...
K060462 · MXZ
Lab Vision Corp.
Pathology · 61d
Cleared Apr 24, 2006
DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM
K060640 · EHD
Dentamerica
Radiology · 45d
Cleared Apr 24, 2006
ADPER PROMPT, ADPER PROMPT L-POP
K060684 · KLE
3M Espe AG Dental Products
Dental · 40d
Cleared Apr 24, 2006
SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION...
K060733 · LZA
Barriermed, Inc.
General Hospital · 35d
Cleared Apr 24, 2006
SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM
K060807 · DQY
Biotronik, Inc.
Cardiovascular · 31d
Cleared Apr 24, 2006
BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850
K060865 · DWJ
Arizant Healthcare, Inc.
Cardiovascular · 25d
Cleared Apr 24, 2006
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS...
K060940 · JIX
Ortho-Clinical Diagnostics, Inc.
Immunology · 18d
Cleared Apr 21, 2006
XLTEK EMU40 EEG HEADBOX, MODEL PK1072
K053386 · GWQ
Excel Tech. , Ltd.
Neurology · 137d
Cleared Apr 21, 2006
OHMEGA
K060166 · FFX
Medical Measurement Systems B.V.
Gastroenterology & Urology · 88d
Cleared Apr 21, 2006
BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX...
K060169 · GEI
Barrx Medical, Incorporated
General & Plastic Surgery · 88d