FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
121513–121536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 1991
MODIFIED AEROCHAMBER WITH MASK
K900576 · CCQ
Monaghan Medical Corp.
Anesthesiology · 460d
Cleared May 13, 1991
MENS-O-MATIC I
K904234 · GZJ
Monad Corp.
Neurology · 248d
Cleared May 13, 1991
MENS-O-MATIC 2000
K904235 · GZJ
Monad Corp.
Neurology · 250d
Cleared May 13, 1991
MICRO DERM
K904258 · GZJ
Monad Corp.
Neurology · 241d
Cleared May 13, 1991
MENS-O-MATIC 3000
K904260 · GZJ
Monad Corp.
Neurology · 241d
Cleared May 13, 1991
MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS
K904288 · GZJ
Monad Corp.
Neurology · 236d
Cleared May 13, 1991
MENS FREEDOM MICRO
K904430 · GZJ
Monad Corp.
Neurology · 250d
Cleared May 13, 1991
MEDTRONIC SULLIVAN NASAL CPAP SYSTEM
K905404 · BZD
Medtronic Vascular
Anesthesiology · 161d
Cleared May 13, 1991
COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM
K910194 · BZD
Puritan Bennett Corp.
Anesthesiology · 117d
Cleared May 13, 1991
INTRAVASCULAR IMAGING SYSTEM/MODIFIED
K910281 · JOP
Intertherapy, Inc.
Cardiovascular · 110d
Cleared May 13, 1991
MINISCOPE
K910587 · HRX
Citation Medical Corp.
Orthopedic · 90d
Cleared May 13, 1991
MENTOR(R) SUR-E-TROL(R)
K910637 · FRN
Mentor O & O, Inc.
General Hospital · 89d
Cleared May 13, 1991
PS OMNIFIT NORMALIZED HIP STEM SERIES
K910662 · JDI
Osteonics Corp.
Orthopedic · 88d
Cleared May 13, 1991
PUMP VAC PLUS
K910907 · HET
Marlo Surgical Technology
Obstetrics & Gynecology · 69d
Cleared May 13, 1991
INVOTEC EAR DRAPE
K911039 · KKX
Invotec International, Inc.
General Hospital · 66d
Cleared May 13, 1991
OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS
K911108 · LZU
G.W.B. Intl., Ltd.
Ophthalmic · 70d
Cleared May 13, 1991
QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER
K911369 · MDM
Deroyal Industries, Inc.
General & Plastic Surgery · 46d
Cleared May 13, 1991
PRECISION GLIDE - ENHANCED SURGICAL BLADE
K911913 · GES
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 13d
Cleared May 13, 1991
DISPOSABLE ISOLATION GOWN
K911921 · FYB
Liaoning-Usa Corp.
General Hospital · 13d
Cleared May 10, 1991
UCEZ - STERILE LENS FOG REDUCTION DEVICE
K905590 · OCT
Inman Liebelt Corp.
Gastroenterology & Urology · 148d
Cleared May 10, 1991
BACTI-SWAB
K910180 · JSM
Remel Co.
Microbiology · 115d
Cleared May 10, 1991
HITT BY HEMOCHRON(R)
K910181 · KFF
International Technidyne Corp.
Hematology · 114d
Cleared May 10, 1991
DOCUMENT REFLECTANCE II LINEARITY TEST SET
K910440 · JJY
Casco Standards
Chemistry · 99d
Cleared May 10, 1991
SUPERSERUM REAGENT (SSR)
K910646 · JKA
International Technidyne Corp.
Chemistry · 86d