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
122425–122448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 16, 1991
EMISSION TOMOGRAPHY CAROUSEL
K896151 · KPS
Atf Consolidated
Radiology · 539d
Cleared Apr 16, 1991
DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP
K903298 · ELC
Micro Motors, Inc.
Dental · 266d
Cleared Apr 16, 1991
SHIMADZU IMAGE PROCESSOR DFS-500
K905132 · LLZ
Shimadzu Medical Systems
Radiology · 152d
Cleared Apr 16, 1991
CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL
K905457 · DIF
Consolidated Technologies, Inc.
Chemistry · 132d
Cleared Apr 16, 1991
MASTER FLOW I.V. PUMPETTE
K905497 · LDR
The Master Medical Corp.
General Hospital · 130d
Cleared Apr 16, 1991
STAT 2 IV PUMPETTE
K905498 · LDR
The Master Medical Corp.
General Hospital · 130d
Cleared Apr 16, 1991
HELENA THROMBOPLASTIN REAGENT WITH DILUENT
K905807 · GJS
Helena Laboratories
Hematology · 110d
Cleared Apr 16, 1991
NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION
K910213 · LHI
Abbott Laboratories
General Hospital · 96d
Cleared Apr 16, 1991
IMMULITE(TM) TOTAL T4
K910261 · KLI
Cirrus Diagnostics, Inc.
Chemistry · 84d
Cleared Apr 16, 1991
Y ADAPTOR
K910321 · KOC
Akcess Medical Products, Inc.
Gastroenterology & Urology · 82d