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
56569–56592 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 2008
ELEXOMA MEDIC
K070412 · QJQ
Redplane AG
Neurology · 464d
Cleared May 21, 2008
SONOCA 180/195 WOUND CARE SYSTEM
K072904 · LFL
Soering GmbH
General & Plastic Surgery · 223d
Cleared May 21, 2008
SMITH & NEPHEW INSTRUMENT TRAYS
K073551 · KCT
Smith & Nephew Inc., Endoscopy Div.
General Hospital · 155d
Cleared May 21, 2008
DENTAL CERAMIC
K080479 · EIH
Dmg USA, Inc.
Dental · 89d
Cleared May 21, 2008
MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS
K080598 · NHA
Intra-Lock International
Dental · 79d
Cleared May 21, 2008
NOVEL SPINAL SPACER SYSTEM
K080699 · MQP
Alphatec Spine, Inc.
Orthopedic · 70d
Cleared May 21, 2008
CONQUEST SPINAL SYSTEM
K080767 · MNI
Life Spine
Orthopedic · 64d
Cleared May 21, 2008
ECHELON GRAY CARTRIDGE, MODEL ERC45M
K080839 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 57d
Cleared May 21, 2008
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K081046 · DYB
Terumo Medical Corp.
Cardiovascular · 37d
Cleared May 20, 2008
XTJF TYPE Q160VF1
K080403 · FDT
Olympus Medical Systems Corporation
Gastroenterology & Urology · 96d
Cleared May 20, 2008
CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX
K080946 · KNS
Conmed Endoscopic Technologies, Inc.
Gastroenterology & Urology · 47d
Cleared May 20, 2008
NEUTROPHASE
K081009 · KMF
Novabay Pharmaceuticals
General & Plastic Surgery · 42d
Cleared May 20, 2008
POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
K081040 · LYY
Pt.Shamrock Manufacturing Corp.
General Hospital · 39d
Cleared May 20, 2008
OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)
K081281 · MUJ
Nucletron Corporation
Radiology · 14d
Cleared May 19, 2008
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE
K071889 · DSI
Ge Healthcare
Cardiovascular · 315d
Cleared May 19, 2008
INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING,...
K072600 · MQH
Sunlight Medical, Inc.
Obstetrics & Gynecology · 248d
Cleared May 19, 2008
MODIFICATION TO 3M TEGADERM CHG DRESSING
K080620 · FRO
3M Company-3M Health Care
General & Plastic Surgery · 76d
Cleared May 16, 2008
BI-RADS COMPANION
K072258 · LLZ
Almen Laboratories, Inc.
Radiology · 276d
Cleared May 16, 2008
SUBDERMAL NEEDLE ELECTRODES
K072276 · GXZ
Xian Friendship Electronics Co., Ltd.
Neurology · 275d
Cleared May 16, 2008
POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH...
K072300 · LYY
Perusahaan Pelindung Getah (M) Sdn Bhd
General Hospital · 273d
Cleared May 16, 2008
DIO BIOTITE-H IMPLANT SYSTEM
K073070 · DZE
Dio Department Dsi, Inc.
Dental · 199d
Cleared May 16, 2008
MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM
K080029 · KRR
Mako Surgical Corp.
Orthopedic · 133d
Cleared May 16, 2008
SHUNTCHECK - CSF SHUNT FLOW DETECTOR
K080168 · JXG
Neuro Diagnostic Devices
Neurology · 114d
Cleared May 16, 2008
SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL...
K080439 · BZD
Mallinckrodt Developpement France
Anesthesiology · 87d