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
121825–121848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 1991
ENDOPATH VERESS NEEDLE
K910855 · FHP
Symbiosis Corp.
Gastroenterology & Urology · 49d
Cleared Apr 18, 1991
VARIOUS TEMPLATE APPLICATORS
K910862 · IWJ
Best Industries
Radiology · 48d
Cleared Apr 18, 1991
MODEL 5857-3M LEAD END CAP KIT
K911048 · DTD
Medtronic Vascular
Cardiovascular · 41d
Cleared Apr 18, 1991
TAN CHONG GLOVE, HYPOALLERGENIC
K911146 · LYY
Boston Medical Corp.
General Hospital · 42d
Cleared Apr 18, 1991
INTIMAX(TM) IRRIGATION CATHETER
K911181 · GCA
Applied Vascular Devices, Inc.
Gastroenterology & Urology · 31d
Cleared Apr 18, 1991
ANTIMICROBIAL AMIKACIN
K911303 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 24d
Cleared Apr 18, 1991
SOPHYCAMERA DSX BODYTRAK
K911346 · IYX
Sopha Medical Systems, Inc.
Radiology · 22d
Cleared Apr 17, 1991
ALLERGEN MODULES FOR ALASTAT TM
K894227 · DHB
Diagnostic Products Corp.
Immunology · 667d
Cleared Apr 17, 1991
THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER
K900197 · EWO
Sound Linked Data, Inc.
Ear, Nose, Throat · 456d
Cleared Apr 17, 1991
CATHETER, NASAL, OXYGEN
K902420 · CAT
Gainor Medical Europe, Ltd.
Anesthesiology · 321d
Cleared Apr 17, 1991
QUIDEL HELICOBACTER PYLORI TEST
K903099 · LYR
Quidel Corp.
Microbiology · 278d
Cleared Apr 17, 1991
DW237
K904876 · EJS
Ivoclar North America, Inc.
Dental · 169d
Cleared Apr 17, 1991
OPUS CMV TEST SYSTEM
K905257 · LIN
Pb Diagnostic Systems, Inc.
Microbiology · 147d
Cleared Apr 17, 1991
DRESSER ARGUS P/N 1818
K905304 · BTM
Dresser Argus, Inc.
Anesthesiology · 140d
Cleared Apr 17, 1991
MOBILE TREATMENT CART
K910243 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 85d
Cleared Apr 17, 1991
PATIENT GAS SAMPLING LINE FOR OHMEDA 6000
K910509 · CCK
Intertech Resources, Inc.
Anesthesiology · 71d
Cleared Apr 17, 1991
IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE
K910816 · KDD
Insight International, Inc.
General & Plastic Surgery · 50d
Cleared Apr 17, 1991
OXYFRESH OXYCARE 3000
K910832 · EFS
Oxyfresh
Dental · 49d
Cleared Apr 17, 1991
ANTIMICROBIAL AMPICILLIN/SULBACTAM
K911186 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 30d
Cleared Apr 17, 1991
ANTIMICROBIAL CEFUROXIME
K911187 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 30d
Cleared Apr 17, 1991
PHONAK 9800 SC-AF ITE HEARING INSTRUMENT
K911210 · ESD
Phonak, Inc.
Ear, Nose, Throat · 29d
Cleared Apr 17, 1991
PHONAK 9100 SC-AF ITE HEARING INSTRUMENT
K911211 · ESD
Phonak, Inc.
Ear, Nose, Throat · 29d
Cleared Apr 17, 1991
TRAY DOUGH
K911225 · KGS
The Hygenic Corp.
General & Plastic Surgery · 27d
Cleared Apr 17, 1991
ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED
K911511 · DGO
Diagnostic Products Corp.
Immunology · 13d