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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
50785–50808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 2010
SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM
K100401 · ELC
Hu-Friedy Mfg. Co., Inc.
Dental · 42d
Cleared Mar 30, 2010
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
K100559 · HIH
Interlace Medical, Inc.
Obstetrics & Gynecology · 29d
Cleared Mar 30, 2010
ARSTASIS ACCESS SYSTEM
K100615 · DYB
Arstasis, Inc.
Cardiovascular · 26d
Cleared Mar 30, 2010
INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL...
K100641 · GEI
Relievant Medsystems
General & Plastic Surgery · 25d
Cleared Mar 30, 2010
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K100671 · LYC
Novabone Products, LLC
Dental · 21d
Cleared Mar 30, 2010
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K100712 · FCG
Boston Scientific Corporation
Gastroenterology & Urology · 18d
Cleared Mar 29, 2010
BIOPLEX 2200 MMRV IGG
K091616 · OPL
Bio-Rad Laboratories
Microbiology · 299d
Cleared Mar 29, 2010
GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM
K092493 · HRS
Gpc Medical, Ltd.
Orthopedic · 227d
Cleared Mar 29, 2010
ELECSYS CK-MB CALCHECK 5
K093582 · JJX
Roche Diagnostics
Chemistry · 130d
Cleared Mar 29, 2010
SYNTHES STERNAL FIXATION SYSTEM
K093772 · HRS
Synthes
Orthopedic · 111d
Cleared Mar 29, 2010
SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES
K093928 · HRS
Synthes (Usa)
Orthopedic · 97d
Cleared Mar 29, 2010
STAIR SYSTEMS PACS & DICOM VIEWER
K100236 · LLZ
Stair Systems, Inc.
Radiology · 62d
Cleared Mar 29, 2010
ARTISAN AESTHETIC SYSTEM
K100270 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 59d
Cleared Mar 29, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100324 · LYZ
Tangshan Hengtong Plastic Products Co.
General Hospital · 53d
Cleared Mar 29, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100337 · LYZ
Tangshan Qixin Glove Co., Ltd.
General Hospital · 55d
Cleared Mar 29, 2010
APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK
K100555 · LPH
Omni Life Science, Inc.
Orthopedic · 28d
Cleared Mar 29, 2010
TELAVANCIN 30 UG, BBL SENSI-DISC
K100722 · JTN
Becton, Dickinson and Company
Microbiology · 14d
Cleared Mar 26, 2010
MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION
K091940 · GWF
Tonica Elektronik A/S
Neurology · 269d
Cleared Mar 26, 2010
FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217
K092061 · DXN
Genexel Medical Instrument, Inc.
Cardiovascular · 261d
Cleared Mar 26, 2010
TORQMAX SHEATH GRIP ACCESSORY
K093257 · OFC
Spectranetics Corp.
Cardiovascular · 158d
Cleared Mar 26, 2010
MOVES
K093261 · BTL
Thornhill Research, Inc.
Anesthesiology · 158d
Cleared Mar 26, 2010
PIVIT A/B ST AND PIVIT A/B ST-R
K093524 · FTL
Tyrx, Inc.
General & Plastic Surgery · 130d
Cleared Mar 26, 2010
INDUS ANTERIOR CERVICAL PLATE SYSTEM
K093776 · KWQ
Spinefrontier, Inc.
Orthopedic · 108d
Cleared Mar 26, 2010
CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265
K093941 · CGA
Taidoc Technology Corporation
Chemistry · 94d