FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
128689–128712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1989
SITE 810E PHOTOCOAGULATOR AND ACCESSORIES
K895663 · GEX
Site Microsurgical Systems, Inc.
General & Plastic Surgery · 75d
Cleared Dec 04, 1989
BREVET FLOSS PICK (AUTOCLAVE STERILIZER)
K895958 · EKJ
Brevet, Inc.
Dental · 54d
Cleared Dec 04, 1989
GNATHOMAT ARTICULATOR
K896131 · EJP
Ivoclar North America, Inc.
Dental · 42d
Cleared Dec 04, 1989
STERILE SURGICAL DRAPES AND SHEETS
K896367 · KKX
Clinitech, Inc.
General Hospital · 28d
Cleared Dec 04, 1989
MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT
K896585 · DBF
Medix Biotech, Inc.
Immunology · 13d
Cleared Dec 04, 1989
CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY
K896592 · DHB
Ciba Corning Diagnostics Corp.
Immunology · 13d
Cleared Dec 01, 1989
OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE
K883400 · KPE
Abbott Laboratories
General Hospital · 476d
Cleared Dec 01, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891493 · LYY
Cinderella Ent. Co., Ltd.
General Hospital · 260d
Cleared Dec 01, 1989
PATIENT EXAMINATION GLOVES
K892279 · LYY
Aek Rubber Product Sdn. Bhd.
General Hospital · 241d
Cleared Dec 01, 1989
STETH-SHIELD(TM)
K892890 · DQD
North East Technology
Cardiovascular · 225d
Cleared Dec 01, 1989
3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET
K894986 · OCZ
North American Sterilization &...
Gastroenterology & Urology · 115d
Cleared Dec 01, 1989
S.A.F. ACETABULAR CUP
K895157 · KWA
Synergy Orthopaedics Intl., Inc.
Orthopedic · 113d
Cleared Dec 01, 1989
BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST
K895362 · JTT
Bd Becton Dickinson Vacutainer...
Microbiology · 94d
Cleared Dec 01, 1989
OSBON PERSONAL LUBRICANT
K895406 · KMJ
Osbon Medical Systems, Ltd.
General Hospital · 86d
Cleared Dec 01, 1989
BLUNT NEEDLE PORT/I.V. PORT
K895480 · FPA
Applied Medical Technologies
General Hospital · 81d
Cleared Dec 01, 1989
LATEX PATIENT EXAMINATION GLOVES
K895488 · LYY
Zhong YI Latex Products Factory
General Hospital · 91d
Cleared Dec 01, 1989
MILENIA(TM) HCG (MKCG1,5)
K895809 · JHI
Diagnostic Products Corp.
Chemistry · 90d
Cleared Dec 01, 1989
NEEDLEPOINT GUARD
K895831 · FMF
Needlepoint Guard, Inc.
General Hospital · 60d
Cleared Dec 01, 1989
ISOSCREEN-CK CONFIRMATORY KIT
K895870 · JHY
Roche Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Dec 01, 1989
BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM
K895886 · KWL
Biopro, Inc.
Orthopedic · 57d
Cleared Dec 01, 1989
IMMUNOCARD HCG II-S TEST KIT
K895912 · JHI
Disease Detection International, Inc.
Chemistry · 52d
Cleared Dec 01, 1989
STRAWBERRY SCENTED LATEX EXAMINATION GLOVES
K896135 · LYY
Arista Latindo Industrial Ltd. P.T
General Hospital · 43d
Cleared Dec 01, 1989
SCHNEIDER STENT WALLSTENT ENDOSCOPIC BILIARY ENDO.
K896163 · FGE
Schneider Stent
Gastroenterology & Urology · 38d
Cleared Dec 01, 1989
ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR
K896196 · HRX
Orthoconcept, Inc.
Orthopedic · 37d