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
57745–57768 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 2007
NOBELACTIVE MULTI UNIT ABUTMENT
K072570 · NHA
Nobel Biocare AB
Dental · 107d
Cleared Dec 28, 2007
PENUMBRA SYSTEM
K072718 · NRY
Penumbra, Inc.
Neurology · 94d
Cleared Dec 28, 2007
EMMA ANALYZER (KPA & MMHG)
K072813 · CCK
Phasein AB
Anesthesiology · 88d
Cleared Dec 28, 2007
OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET
K072937 · GEI
Olsen Medical
General & Plastic Surgery · 73d
Cleared Dec 28, 2007
CADENCE II
K073221 · HGM
Edan Instruments, Inc.
Radiology · 43d
Cleared Dec 28, 2007
ADVANCE 18LP PTA DILATATION CATHETER
K073378 · DQY
Cook, Inc.
Cardiovascular · 25d
Cleared Dec 28, 2007
SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM
K073436 · GEX
Lutronic Corporation
General & Plastic Surgery · 22d
Cleared Dec 27, 2007
POLYBONE
K070012 · GXP
Kyung Won Medical Co., Ltd.
Neurology · 358d
Cleared Dec 27, 2007
SELF SEAL STERILIZATION POUCH
K071886 · FRG
Shanghai Jianzhong Medical Packaging...
General Hospital · 171d
Cleared Dec 27, 2007
SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER
K072159 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 143d
Cleared Dec 27, 2007
CYNOSURE YAG FAMILY LASER
K072484 · GEX
Cynosure, Inc.
General & Plastic Surgery · 114d
Cleared Dec 27, 2007
ARTISTE MV SA
K072485 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 114d
Cleared Dec 27, 2007
CHOLESTRAK HDL CHOLESTEROL HOME TEST
K072836 · LBS
Accutech, LLC
Chemistry · 85d
Cleared Dec 27, 2007
REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM
K072996 · BZD
Respironics, Inc.
Anesthesiology · 64d
Cleared Dec 27, 2007
HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
K073178 · JPK
R&D Systems, Inc.
Hematology · 44d
Cleared Dec 27, 2007
REHASTIM & REHAMOVE
K073237 · GZI
Hasomed GmbH
Neurology · 41d
Cleared Dec 27, 2007
HEMOSIL FIBRINOGEN-C
K073367 · KQJ
Instrumentation Laboratory CO
Hematology · 27d
Cleared Dec 26, 2007
THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE)
K072231 · KWQ
Esm Technologies, LLC
Orthopedic · 138d
Cleared Dec 26, 2007
FINESSE SYSTEM
K072261 · GEI
Primaeva Medical, Inc.
General & Plastic Surgery · 134d
Cleared Dec 26, 2007
STORZ MODULITH LITHOTRIPTER SLX-F2-F180
K072788 · LNS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 86d
Cleared Dec 26, 2007
ORACLE SPACER, OPAL SPACER
K072791 · MAX
Synthes Spine
Orthopedic · 86d
Cleared Dec 26, 2007
SPIROBANK G
K072979 · BZG
Mir Medical Intl. Research Srl
Anesthesiology · 65d
Cleared Dec 26, 2007
308 DERMATOLOGICAL EXCIMER SYSTEM
K073066 · FTC
Quantel Medical, Inc.
General & Plastic Surgery · 57d
Cleared Dec 26, 2007
LUCENT MAGNUM
K073348 · MAX
Spinal Elements, Inc.
Orthopedic · 27d