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
99553–99576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1995
VOLUMETRIC INFUSION PUMP
K953098 · FRN
Baxter Healthcare Corp
General Hospital · 172d
Cleared Dec 22, 1995
Multi Side Hole lnfusion System
K953384 · QEY
AngioDynamics, Inc.
Cardiovascular · 156d
Cleared Dec 22, 1995
COBRASCAN CX-312
K953942 · LMA
Radiographic Digital Imaging, Inc.
Radiology · 141d
Cleared Dec 22, 1995
ROTABLATOR ROTATIONAL ANGIOPLASTY
K953997 · MCW
Heart Technology Mfg., Inc.
Cardiovascular · 120d
Cleared Dec 22, 1995
SPECTRADIGITAL SERIES V250DSP
K954129 · KPS
Hitachi Medical Corp. of America
Radiology · 112d
Cleared Dec 22, 1995
HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS
K954143 · KPS
Hitachi Medical Corp. of America
Radiology · 112d
Cleared Dec 22, 1995
GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE
K954306 · HQB
Gamp & Assoc.
Ophthalmic · 98d
Cleared Dec 22, 1995
GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE
K954307 · HQB
Gamp & Assoc.
Ophthalmic · 98d
Cleared Dec 22, 1995
GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE
K954308 · HQB
Gamp & Assoc.
Ophthalmic · 98d
Cleared Dec 22, 1995
SURELOC CIRCUIT CONNECTOR
K954383 · BZA
Polamedco, Inc.
Anesthesiology · 94d
Cleared Dec 22, 1995
WANG TRANSENDOSCOPIC ASPIRATION NEEDLE
K954519 · FBK
Mill-Rose Laboratory
Gastroenterology & Urology · 85d
Cleared Dec 22, 1995
LUNG DIFFUSION MIXTURE
K954542 · BXK
Liquid Technology Corp.
Anesthesiology · 84d
Cleared Dec 22, 1995
GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT
K954562 · HHT
Gynetech, Inc.
Obstetrics & Gynecology · 81d
Cleared Dec 22, 1995
NERVE LOCATOR/MONITOR SYSTEM MODIFICATION
K954601 · ETN
Rln Systems, Inc.
Ear, Nose, Throat · 101d
Cleared Dec 22, 1995
RADIOSURGERY VERIFICATION PHANTOM
K954634 · IYE
The Phantom Laboratory, Inc.
Radiology · 77d
Cleared Dec 22, 1995
WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP
K954649 · GCJ
Wilson Greatbatch Technologies, Inc.
General & Plastic Surgery · 73d
Cleared Dec 22, 1995
MIRACLE EAR AND AUDIOTONE
K954941 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 53d
Cleared Dec 22, 1995
TRANSIT INFUSION CATHETER WITH SIDEHOLES
K954949 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 53d
Cleared Dec 22, 1995
MOBILE X-RAY SYSTEM
K955036 · IZL
Shimadzu Corp.
Radiology · 49d
Cleared Dec 22, 1995
PLAYSKOOL
K955069 · KKO
Hasbro, Inc.
Dental · 46d
Cleared Dec 22, 1995
SENSOR PAD
K955249 · IZH
Inventive Products, Inc.
Radiology · 37d
Cleared Dec 22, 1995
SOF - ABRASION BUR
K955294 · EQJ
Trebay Medical Corp.
Ear, Nose, Throat · 35d
Cleared Dec 22, 1995
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
K955516 · JOH
Boston Medical Products, Inc.
Anesthesiology · 18d
Cleared Dec 22, 1995
TREBAY SCOPE IRRIGATED CLEARING SLEEVE
K955560 · EOB
Trebay Medical Corp.
Ear, Nose, Throat · 16d