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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
118249–118272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1992
STREP A OIA
K915758 · GTZ
Biosearch Medical Products, Inc.
Microbiology · 38d
Cleared Jan 30, 1992
MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR
K915769 · DXH
Medtronic Vascular
Cardiovascular · 37d
Cleared Jan 30, 1992
CALIBRATOR
K915797 · JIX
Alko Diagnostic Corp.
Chemistry · 37d
Cleared Jan 30, 1992
MILENIA DATA REDUCTION
K915806 · JJX
Diagnostic Products Corp.
Chemistry · 37d
Cleared Jan 30, 1992
AUDIOTONE MODEL A-96
K920093 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 22d
Cleared Jan 29, 1992
PSF-50ET
K910850 · ITX
Toshiba America Medical Systems, In.C
Radiology · 336d
Cleared Jan 28, 1992
MCAFFEE UNIVERSAL SPINAL SYSTEM (MUSS)
K901507 · KWQ
Kirschner Medical Corp.
Orthopedic · 669d
Cleared Jan 28, 1992
MODEL TM101 TEMPERATURE MONITOR
K902386 · FLL
Fisher & Paykel Electronics , Ltd.
General Hospital · 608d
Cleared Jan 28, 1992
DATASCOPE MODEL VISA CENTRAL MONITOR
K913576 · DSI
Accucore, Inc.
Cardiovascular · 169d
Cleared Jan 28, 1992
CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM
K913986 · FGE
Medical Dynamics, Inc.
Gastroenterology & Urology · 145d
Cleared Jan 28, 1992
ABL505 BLOOD GAS & ELECTROLYTE SYSTEM
K914166 · CHL
Radiometer America, Inc.
Chemistry · 133d
Cleared Jan 28, 1992
HORIZON 9000/HIS OPTION AMPLIFIER
K914381 · DRR
Mennen Medical, Inc.
Cardiovascular · 117d
Cleared Jan 28, 1992
BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT
K915084 · CDT
Beckman Instruments, Inc.
Chemistry · 77d
Cleared Jan 28, 1992
DIMENSION AR CLINICAL CHEMISTRY SYSTEM
K915106 · JJE
Dupont Medical Products
Chemistry · 76d
Cleared Jan 28, 1992
CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT
K915235 · CDX
Incstar Corp.
Chemistry · 67d
Cleared Jan 28, 1992
ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL
K915516 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Jan 28, 1992
MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT
K920046 · DBF
Medix Biotech, Inc.
Immunology · 22d
Cleared Jan 28, 1992
AUDIOTONE MODEL A97
K920092 · LYY
Miracle-Ear, Inc.
General Hospital · 20d
Cleared Jan 27, 1992
DISPOSABLE SLIDE VALVE MANIFOLD
K913094 · DQO
Professional Medical Services
Cardiovascular · 199d
Cleared Jan 27, 1992
BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER
K913341 · EZC
C.R. Bard, Inc.
Gastroenterology & Urology · 185d
Cleared Jan 27, 1992
VENUS HIP
K913708 · LWJ
Turnkey Intergration USA, Inc.
Orthopedic · 164d
Cleared Jan 27, 1992
COBE BRAT SYSTEMS WITHOUT REINFUSION PROTECTION
K913773 · CAC
Cobe Cardiovascular, Inc.
Anesthesiology · 157d
Cleared Jan 27, 1992
LM-90 ESU
K913799 · GEI
Keisegang Medical, Inc.
General & Plastic Surgery · 154d
Cleared Jan 27, 1992
SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS
K914022 · LFY
Pharmacia Diagnostics, Inc.
Microbiology · 140d