FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
80185–80208 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 2001
SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM
K003743 · MAI
Synthes (Usa)
Orthopedic · 67d
Cleared Feb 09, 2001
AML HIP PROSTHESIS
K003800 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 63d
Cleared Feb 09, 2001
POWDERFREE NITRILE PATIENT EXMINATION GLOVE
K003985 · LZA
Guthrie Medicare Products (Melaka)...
General Hospital · 45d
Cleared Feb 09, 2001
COSMIC
K010044 · EJT
Jeneric/Pentron, Inc.
Dental · 35d
Cleared Feb 09, 2001
NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITHOUT GRAPE...
K010095 · LYY
Sgmp Co., Ltd.
General Hospital · 29d
Cleared Feb 09, 2001
SONIC MODEL SO-300
K010102 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 28d
Cleared Feb 09, 2001
MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH...
K010120 · LPH
Exactech, Inc.
Orthopedic · 24d
Cleared Feb 09, 2001
STERILE BUTTON PLATE
K010121 · MBI
Synthes (Usa)
Orthopedic · 24d
Cleared Feb 09, 2001
64 CHANNEL EEG / MODEL NUMBER EX-NW-64
K010150 · GWQ
Excel Tech. , Ltd.
Neurology · 23d
Cleared Feb 09, 2001
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
K010179 · HRX
Ebi, L.P.
Orthopedic · 21d
Cleared Feb 09, 2001
JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE
K010231 · LYY
Jk Gloves Sdn. Bhd.
General Hospital · 16d
Cleared Feb 09, 2001
LATERAL OFFSET PROTRACT PRESS FIT HIP STEM
K010282 · LPH
Stelkast Company
Orthopedic · 10d
Cleared Feb 09, 2001
TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP
K993856 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 452d
Cleared Feb 08, 2001
CEMEX SYSTEM GUN APPLICATION VERSION
K000943 · LOD
Exactech, Inc.
Orthopedic · 322d
Cleared Feb 08, 2001
ORG-9200A
K002068 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 216d
Cleared Feb 08, 2001
THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F
K002712 · FLL
Saat , Ltd.
General Hospital · 161d
Cleared Feb 08, 2001
CANNULATED SCREW SYSTEM
K003496 · HTN
Pioneer Surgical Technology
Orthopedic · 87d
Cleared Feb 08, 2001
LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
K003512 · HQC
A.R.C. Laser AG
Ophthalmic · 86d
Cleared Feb 08, 2001
STYLET KIT, MODELS 6254,6282,6293
K003535 · DRB
Medtronic Vascular
Cardiovascular · 84d
Cleared Feb 08, 2001
FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES
K003586 · MVN
Ciba-Geigy Corp.
Ophthalmic · 80d
Cleared Feb 08, 2001
EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET
K003627 · FMI
Exelint International, Co.
General Hospital · 76d
Cleared Feb 08, 2001
BIOLOK SCREW, BIOSTEON SCREW
K003641 · HWC
Biocomposites, Ltd.
Orthopedic · 73d
Cleared Feb 08, 2001
TAPER-FIT TOTAL HIP SYSTEM
K003666 · JDI
Corin USA
Orthopedic · 72d
Cleared Feb 08, 2001
ENVIVE MINIFORMS
K003843 · HHD
Procter & Gamble Co.
Obstetrics & Gynecology · 58d