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
66889–66912 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 2005
PALAIMPACT
K043504 · EBI
Heraeus Kulzer, Inc.
Dental · 39d
Cleared Jan 28, 2005
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
K043607 · BZD
Respironics, Inc.
Anesthesiology · 29d
Cleared Jan 28, 2005
SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
K050099 · IYN
Kontron Medical Systems Sas
Radiology · 10d
Cleared Jan 27, 2005
F00010 - IV GRAVITY SETWITH MALE LUER SLIP
K042129 · FPA
Cedic S.R.L.
General Hospital · 174d
Cleared Jan 27, 2005
AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304
K042623 · DYB
St. Jude Medical, Daig Division, Inc.
Cardiovascular · 122d
Cleared Jan 27, 2005
BIOMOVE 3000
K042650 · IPF
Curatronic, Ltd.
Physical Medicine · 121d
Cleared Jan 27, 2005
PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037
K042818 · DXN
Matsushita Electric Works, Ltd.
Cardiovascular · 107d
Cleared Jan 27, 2005
SOLITUDE UNIPOLAR HEAD
K042973 · KWL
Ortho Development Corp.
Orthopedic · 91d
Cleared Jan 27, 2005
RANDOX PHENCYCLIDINE ASSAY
K043071 · LCM
Randox Laboratories, Ltd.
Chemistry · 80d
Cleared Jan 27, 2005
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS
K043072 · MKZ
Gen-Probe, Inc.
Microbiology · 80d
Cleared Jan 27, 2005
FUSION FAST
K043471 · ELW
GC America, Inc.
Dental · 42d
Cleared Jan 27, 2005
AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100
K043550 · DXN
Amplife Corporation
Cardiovascular · 35d
Cleared Jan 27, 2005
HORIZON ANGIO CATHLAB
K043564 · DQK
Mennen Medical , Ltd.
Cardiovascular · 31d
Cleared Jan 27, 2005
LAPAROCISION SCOPE CONTROLLER SYSTEM
K050027 · GCJ
Gmp/Companies, Inc.
General & Plastic Surgery · 21d
Cleared Jan 26, 2005
DISTAL RADIO-ULNAR JOINT IMPLANT
K040497 · KXE
Aptis Medical, LLC
Orthopedic · 335d
Cleared Jan 26, 2005
CARDIOSTATION-100 (CS-100)
K041031 · DQK
Us Clover Co.
Cardiovascular · 280d
Cleared Jan 26, 2005
LSA HELIUM
K042596 · IPL
Lifestand
Physical Medicine · 125d
Cleared Jan 26, 2005
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND...
K043065 · DRS
Edwards Lifesciences, LLC
Cardiovascular · 82d
Cleared Jan 26, 2005
LDL-EX SEIKEN ASSAY KIT
K043264 · MRR
Denka Seiken Co., Ltd.
Chemistry · 63d
Cleared Jan 26, 2005
GEODESIC PHOTOGRAMMETRY SYSTEM
K043309 · GWQ
Electrical Geodesics, Incorporated
Neurology · 56d
Cleared Jan 26, 2005
BEWELL, MODEL SC 20
K043326 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 55d
Cleared Jan 26, 2005
CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003
K043583 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Jan 26, 2005
THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06
K043596 · KXK
Theragenics Corp.
Radiology · 28d
Cleared Jan 25, 2005
Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED
K040685 · LWJ
Osteoimplant Technology, Inc.
Orthopedic · 315d