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
90409–90432 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 1998
DIGENE DML 2000 MICROPLATE LUMINOMETER
K980120 · JJQ
Digene Corp.
Chemistry · 24d
Cleared Feb 06, 1998
MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES
K980211 · KNW
Manan Medical Products, Inc.
Gastroenterology & Urology · 16d
Cleared Feb 05, 1998
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K972990 · LNH
GE Medical Systems
Radiology · 177d
Cleared Feb 05, 1998
DYRACT AP RESTORATIVE
K973235 · EBF
Dentsply Intl.
Dental · 161d
Cleared Feb 05, 1998
IMEX STETHODOP
K973336 · JAF
Imex Medical Systems, Inc.
Radiology · 154d
Cleared Feb 05, 1998
HEMORRELIEF DEVICE
K973590 · LKX
A.Stein - Regulatory Affairs Consulting
Gastroenterology & Urology · 136d
Cleared Feb 05, 1998
STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
K973734 · JOL
Welcon, Inc.
General Hospital · 128d
Cleared Feb 05, 1998
AIR OXYGE MIXER
K974372 · BZR
Sk Med
Anesthesiology · 77d
Cleared Feb 05, 1998
EASYBLOOD GAS ANALYZER
K974526 · CHL
Medica Corp.
Chemistry · 65d
Cleared Feb 05, 1998
SINGER ACUPUNCTURE NEEDLES
K974616 · MQX
Lorac, Inc.
General Hospital · 56d
Cleared Feb 05, 1998
ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
K974809 · LSR
Boston Biomedica, Inc.
Microbiology · 44d
Cleared Feb 05, 1998
ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
K974810 · LSR
Boston Biomedica, Inc.
Microbiology · 44d
Cleared Feb 05, 1998
VACUETTE (MULTI-USE HOLDER)
K974873 · JKA
Greiner Meditech, Inc.
Chemistry · 38d
Cleared Feb 05, 1998
CARESIDE BUN
K980057 · CDQ
Exigent Diagnostics, Inc.
Chemistry · 30d
Cleared Feb 05, 1998
VACUTAINER BRAND PRONTO NEEDLES HOLDER
K980098 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 24d
Cleared Feb 04, 1998
ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER
K973938 · JJQ
Sfri, Inc.
Chemistry · 112d
Cleared Feb 04, 1998
CLEARLINE PLUS, DENTAL WATERLINE FILTER
K973996 · EIA
Scitech Solutions, Inc.
Dental · 106d
Cleared Feb 04, 1998
FLEXIBLE TIP DIGITAL THERMOMETER
K974195 · FLL
K-Jump Health Co., Ltd.
General Hospital · 89d
Cleared Feb 04, 1998
PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM
K974203 · MQU
Integrated Orbital Implants, Inc.
Ophthalmic · 86d
Cleared Feb 04, 1998
AURORA TITANIUM SPINAL ROD SYSTEM
K974213 · MNH
United States Surgical, A Division of...
Orthopedic · 86d
Cleared Feb 04, 1998
DENTAL TRAY, STERILE, DISPOSABLE
K974238 · EIA
Trinity Laboratories, Inc.
Dental · 84d
Cleared Feb 04, 1998
GLUMA ONE BOND
K974390 · KLE
Heraeus Kulzer, Inc.
Dental · 75d
Cleared Feb 04, 1998
QUICKSCREEN ONE STEP PCP SCREENING TEST
K974582 · LCM
Phamatech
Toxicology · 58d
Cleared Feb 04, 1998
PARAGON LENS CARE
K974635 · LRX
Paragon Vision Sciences
Ophthalmic · 54d