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
66361–66384 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 2005
BIOLOX DELTA CERAMIC HEADS
K042091 · LZO
Biomet, Inc.
Orthopedic · 234d
Cleared Mar 25, 2005
EPI-K
K043183 · HNO
Moria SA
Ophthalmic · 128d
Cleared Mar 25, 2005
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K043392 · NLH
Alliance Medical Corp.
Cardiovascular · 105d
Cleared Mar 25, 2005
SE INFUSION SYSTEM WITH MMS
K043590 · FRN
Cardinal Health, Alaris Products
General Hospital · 87d
Cleared Mar 25, 2005
MAESTRO CARPAL HEMIARTHROPLASTY
K050028 · KWN
Biomet Manufacturing, Inc.
Orthopedic · 78d
Cleared Mar 25, 2005
MS-930 MARS INFLATE-READ BLOOD PRESSURE MONITOR
K050039 · DXN
Mars Medical Products
Cardiovascular · 77d
Cleared Mar 25, 2005
K-LASER, MODELS 3,4,4D,6D
K050070 · ILY
Eltech S.R.L
Physical Medicine · 72d
Cleared Mar 25, 2005
APOLLO
K050190 · KXJ
Villa Sistemi Medicali S.P.A.
Radiology · 57d
Cleared Mar 25, 2005
PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES
K050295 · MQX
Helio Medical Supplies, Inc.
General Hospital · 46d
Cleared Mar 25, 2005
PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
K050309 · CAP
Viasys Medsystems
Anesthesiology · 45d
Cleared Mar 25, 2005
VISITRAK, VERSION 1, RELEASE 1
K050372 · IYE
Math Resolutions, LLC
Radiology · 39d
Cleared Mar 25, 2005
CORDLESS COIL
K050476 · MOS
Siemens Medical Solution, Inc. USA
Radiology · 29d
Cleared Mar 25, 2005
BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET
K050497 · HWC
Linvatec Corp.
Orthopedic · 25d
Cleared Mar 25, 2005
VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS
K050504 · JJY
Maine Standards Co.
Chemistry · 25d
Cleared Mar 25, 2005
LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I
K050509 · KPS
Cti Pet Systems, Inc.
Radiology · 24d
Cleared Mar 25, 2005
MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS
K050514 · MOS
Mri Devices Corporation
Radiology · 24d
Cleared Mar 25, 2005
GE DATEX-OHMEDA ENGSTROM CARESTATION
K050597 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 16d
Cleared Mar 25, 2005
GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM
K050626 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 14d
Cleared Mar 25, 2005
MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR
K050697 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 7d
Cleared Mar 24, 2005
ENCORE REVERSE SHOULDER PROSTHESIS
K041066 · PHX
Encore Medical, L.P.
Orthopedic · 335d
Cleared Mar 24, 2005
INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001
K041715 · JAQ
Nucletron Corp.
Radiology · 274d
Cleared Mar 24, 2005
OXYBAND WOUND DRESSING
K043063 · NAD
Oxyband Technologies, Inc.
General & Plastic Surgery · 139d
Cleared Mar 24, 2005
CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410
K043454 · MLO
Medicomp, Inc.
Cardiovascular · 99d
Cleared Mar 24, 2005
BIOSYAG 50 MED
K043521 · GEX
Bios S.R.L.
General & Plastic Surgery · 94d