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
71521–71544 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 2003
APAX PACS SYSTEM
K032760 · LLZ
Tis, Inc.
Radiology · 12d
Cleared Sep 16, 2003
AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060
K030504 · MCW
Idev Technologies, Inc.
Cardiovascular · 209d
Cleared Sep 16, 2003
PENTACAM SCHEIMPFLUG CAMERA
K030719 · MXK
Oculus Optikgerate GmbH
Ophthalmic · 193d
Cleared Sep 16, 2003
CANDELA SMOOTHBEAM LASER SYSTEM
K030846 · GEX
Candela Corp.
General & Plastic Surgery · 183d
Cleared Sep 16, 2003
DIOBEAM 830
K031499 · NHN
Soft-Core Texas, Inc.
Physical Medicine · 126d
Cleared Sep 16, 2003
SOPRO 61D
K031593 · GCJ
Sopro
General & Plastic Surgery · 118d
Cleared Sep 16, 2003
OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS
K031632 · DZE
Implant Innovations, Inc.
Dental · 112d
Cleared Sep 16, 2003
MEDLINE REUSABLE SURGICAL GOWNS (100X)
K031933 · FYA
Medline Industries, Inc.
General Hospital · 85d
Cleared Sep 16, 2003
PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16
K031948 · DXZ
Pm Devices, Inc.
Cardiovascular · 84d
Cleared Sep 16, 2003
VINTAGE AL
K032165 · EIH
Shofu Dental Corp.
Dental · 63d
Cleared Sep 16, 2003
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS...
K032529 · HRX
Hydrocision, Inc.
Orthopedic · 32d
Cleared Sep 16, 2003
MODIFICATION TO CONTOUR SE MICROSPHERES
K032542 · HCG
Boston Scientific Corp
Neurology · 29d
Cleared Sep 16, 2003
SHORT INTRODUCER SHEATH
K032569 · DYB
Rex Medical
Cardiovascular · 27d
Cleared Sep 16, 2003
ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300
K032615 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 22d
Cleared Sep 16, 2003
BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000
K032674 · LGZ
Belmont Instrument Corp.
General Hospital · 18d
Cleared Sep 16, 2003
BEDSIDE MONITOR, MODEL OPV-1500
K032749 · MWI
Nihon Kohden America, Inc.
Cardiovascular · 11d
Cleared Sep 15, 2003
LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK...
K023837 · LAF
Princeton BioMeditech Corp.
Toxicology · 301d
Cleared Sep 15, 2003
SALINUM, ORCLAIR
K024148 · LFD
Sinclair Pharmaceuticals, Ltd.
Dental · 273d
Cleared Sep 15, 2003
3I DENTAL IMPLANTS
K030614 · DZE
Implant Innovations, Inc.
Dental · 201d
Cleared Sep 15, 2003
ACUMEN SURGICAL NAVIGATION SYSTEM
K031337 · HAW
Biomet, Inc.
Neurology · 140d
Cleared Sep 15, 2003
FLUORIDE VARNISH
K031932 · LBH
Dentsply Intl.
Dental · 84d
Cleared Sep 15, 2003
ASAP ARTHROSCOPE MODELS
K031972 · HRX
Asap Endoscopic Products GmbH
Orthopedic · 81d
Cleared Sep 15, 2003
INOVO, INC, ECONOMIZER CONSERVING REGULATOR
K031983 · NFB
Inovo, Inc.
Anesthesiology · 81d
Cleared Sep 15, 2003
RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE
K032054 · HAW
Radionics, A Division of Tyco...
Neurology · 75d