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
94009–94032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1997
ALEXANDER MANUFACTURING COMPANY PRCHARGEABLE BATTERY
K970268 · MSG
Alexander Mfg. Co.
Ophthalmic · 67d
Cleared Mar 31, 1997
FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667
K970349 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 60d
Cleared Mar 31, 1997
PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)
K970377 · HNO
Plancon Instruments
Ophthalmic · 56d
Cleared Mar 31, 1997
MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300
K970479 · KZH
Medtronic Minimed
General Hospital · 52d
Cleared Mar 31, 1997
TRX POWER TILT AND RECLINE SYSTEM
K970521 · ITI
Motion Concepts
Physical Medicine · 48d
Cleared Mar 31, 1997
KALGINATE IMPRESSION MATERIAL
K970594 · ELW
Teledyne Water Pik
Dental · 41d
Cleared Mar 31, 1997
EYE TRAY
K970722 · KKX
Trinity Laboratories, Inc.
General Hospital · 32d
Cleared Mar 31, 1997
STYLE EYES OPTICS
K970744 · HQY
Anti-Ray, Inc.
Ophthalmic · 31d
Cleared Mar 28, 1997
NASALFLAIR
K951944 · BZD
Airways Ltd., Inc.
Anesthesiology · 702d
Cleared Mar 28, 1997
CUFFED OROPHARYNGEAL AIRWAY (COPA)
K955721 · CAE
Mallinckrodt Medical
Anesthesiology · 466d
Cleared Mar 28, 1997
C.E. VASCULAR MACHINE
K960840 · JEH
C.E. Diagnosis, Inc.
Anesthesiology · 393d
Cleared Mar 28, 1997
AIRCAST VENAFLOW SYSTEM (MODIFICATION)
K961676 · JOW
Aircast, Inc.
Cardiovascular · 350d
Cleared Mar 28, 1997
BIO-BINKI
K961782 · JAA
Biomni Medical Systems, Inc.
Radiology · 324d
Cleared Mar 28, 1997
GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM
K962687 · JQW
Nichols Institute Diagnostics
Hematology · 260d
Cleared Mar 28, 1997
ERCP CANNULA
K963051 · ODD
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 234d
Cleared Mar 28, 1997
ARTOSCAN M
K963262 · LNH
Biosound, Inc.
Radiology · 220d
Cleared Mar 28, 1997
AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX
K963293 · MSA
Augustine Medical, Inc.
General & Plastic Surgery · 219d
Cleared Mar 28, 1997
FOCUS PV BALLOON DILATATION CATHETER
K963688 · LIT
Cardiovascular Dynamics, Inc.
Cardiovascular · 193d
Cleared Mar 28, 1997
PARAMAX TRIGLYCERID REAGENT
K964346 · CDT
Dade Intl., Inc.
Chemistry · 148d
Cleared Mar 28, 1997
FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC...
K964441 · KNF
Gynecare Innovation Center
Obstetrics & Gynecology · 142d
Cleared Mar 28, 1997
CRYOGEN CRYOSURGICAL SYSTEM
K964971 · GEH
Cryogen, Inc.
General & Plastic Surgery · 106d
Cleared Mar 28, 1997
COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)
K965214 · DTX
Coeur Laboratories, Inc.
Cardiovascular · 88d
Cleared Mar 28, 1997
PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE...
K965239 · CBN
Accutron, Inc.
Anesthesiology · 87d
Cleared Mar 28, 1997
GYREX 2T-PRESTIGE
K970005 · LNI
Elscint, Inc.
Radiology · 85d