FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93313–93336 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 1997
POST-STOP EPISTAXIS CATHETER
K972078 · EMX
Boston Medical Products, Inc.
Ear, Nose, Throat · 37d
Cleared Jul 10, 1997
PRO CHECK DIGITAL PACIFIER THERMOMETER
K972259 · FLL
Micro Weiss Electronics
General Hospital · 23d
Cleared Jul 09, 1997
RPI DUAL PORT IRRIGATION ADAPTER
K964920 · KNT
Ridge Products, Inc.
Gastroenterology & Urology · 212d
Cleared Jul 09, 1997
ESCORT II CLINICAL THERMOMETRY MODULE (CTM)
K970011 · FLL
Medical Data Electronics
General Hospital · 188d
Cleared Jul 09, 1997
THERAPLAN PLUS VERSION 1.2
K970236 · IYE
Theratronics, Inc.
Radiology · 169d
Cleared Jul 09, 1997
34MM SCARF THREAD-HEAD(TM) SCREW
K971068 · HWC
Landos, Inc.
Orthopedic · 107d
Cleared Jul 09, 1997
TWIST-OFF (TM) SCREW
K971069 · HWC
Landos, Inc.
Orthopedic · 107d
Cleared Jul 09, 1997
SCARF THREAD-HEAD (TM) HEAD SCREW
K971070 · HWC
Landos, Inc.
Orthopedic · 107d
Cleared Jul 09, 1997
INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE
K971079 · KQX
Interlogics, Inc.
Neurology · 106d
Cleared Jul 09, 1997
NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES
K971194 · LDD
Nihon Kohden America, Inc.
Cardiovascular · 99d
Cleared Jul 09, 1997
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K971321 · HRS
Osteonics Corp.
Orthopedic · 90d
Cleared Jul 09, 1997
AMS MAINSTAY UROLOGIC BONE ANCHOR
K971332 · MBI
American Medical Systems, Inc.
Orthopedic · 90d
Cleared Jul 09, 1997
EPITECH ISLAND DRESSINGS
K971337 · KMF
Rynel, Ltd. Inc.
General & Plastic Surgery · 90d
Cleared Jul 09, 1997
BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM
K971358 · MAI
Arthrex, Inc.
Orthopedic · 89d
Cleared Jul 09, 1997
POWDER-FREE DURAPRENE STERILE SYNTHETIC SURGICAL GLOVES
K971381 · KGO
Allegiance Healthcare Corp.
General Hospital · 86d
Cleared Jul 09, 1997
SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE...
K971404 · GEX
Schwartz Electro-Optics, Inc.
General & Plastic Surgery · 84d
Cleared Jul 09, 1997
OSTEONICS ALUMINA C-TAPER HEAD
K971409 · LZO
Osteonics Corp.
Orthopedic · 84d
Cleared Jul 09, 1997
HEADLOC CERAMIC HEAD
K971426 · LZO
Ortho Development Corp.
Orthopedic · 83d
Cleared Jul 09, 1997
INTERSEAL ACETABULAR SCREW HOLE PLUG
K971429 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 82d
Cleared Jul 09, 1997
HEADLOC CERAMIC FEMORAL HEADS
K971435 · LZO
Ortho Development Corp.
Orthopedic · 82d
Cleared Jul 09, 1997
OSTEO COMPRESSION HIP SCREW SYSTEM
K971654 · HWC
Osteonics Corp.
Orthopedic · 64d
Cleared Jul 09, 1997
BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER
K971700 · ITX
Biosound, Inc.
Radiology · 62d
Cleared Jul 09, 1997
ASC BALANCE MIDDLEWEIGHT GUIDE WIRE
K971815 · DQX
Guidant Corp.
Cardiovascular · 54d
Cleared Jul 09, 1997
SP4044 & SP4055 LUX MODULES
K972026 · ELC
Satelec
Dental · 37d