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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
44521–44544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 2012
VALEO VT-601 SERIES IR THERMOMETER
K111463 · FLL
Valeo Corp.
General Hospital · 267d
Cleared Feb 17, 2012
TI-BASE ABUTMENT, 1 CONNECT ABUTMENT
K111935 · NHA
Nt-Trading GmbH and CO KG
Dental · 224d
Cleared Feb 17, 2012
VITEK 2 STREPTOCOCCUS ERYTHROMYCIN
K111976 · LON
bioMerieux, Inc.
Microbiology · 220d
Cleared Feb 17, 2012
GEODESIC EEG MOBILE 100 (GEM 100)
K112353 · GWQ
Electrical Geodesics, Inc.
Neurology · 185d
Cleared Feb 17, 2012
POWDERFREE POLYISOPRENE SURGICAL GLOVES
K112654 · KGO
Pt. Medisafe Technologies
General Hospital · 158d
Cleared Feb 17, 2012
TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)
K112781 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 144d
Cleared Feb 17, 2012
EQUIVITAL
K113054 · MHX
Hidalgo Limited
Cardiovascular · 127d
Cleared Feb 17, 2012
NANOBLUTM 500
K113206 · LBI
Draeger Medical Systems, Inc.
General Hospital · 108d
Cleared Feb 17, 2012
ACU-CUT VERTEBRAL AUGMENTATION SYSTEM
K113452 · NDN
Ascendx Spine, Inc.
Orthopedic · 88d
Cleared Feb 17, 2012
VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER
K113505 · FMI
Greiner Bio-One North America, Inc.
General Hospital · 81d
Cleared Feb 17, 2012
WAGNER CONE PROSTHESIS SYSTEM
K113556 · LZO
Zimmer GmbH
Orthopedic · 78d
Cleared Feb 17, 2012
HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY
K113627 · MTJ
Orthocon
General & Plastic Surgery · 71d
Cleared Feb 17, 2012
CLOSER TO NATURE ELECTRIC BREAST PUMP
K113664 · HGX
Mayborn Group Limited
Obstetrics & Gynecology · 66d
Cleared Feb 17, 2012
NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
K120081 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 37d
Cleared Feb 17, 2012
ACE STAPLER AND CARTRIDGE
K120147 · OCW
Barosense, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 17, 2012
ARTHREX KNOTLESS SUTURETAK ANCHOR
K120155 · MBI
Arthrex, Inc.
Orthopedic · 30d
Cleared Feb 17, 2012
ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM
K120163 · HRS
Acute Innovations, LLC
Orthopedic · 29d
Cleared Feb 17, 2012
AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET
K120272 · KNT
Kentec Medical, Inc.
Gastroenterology & Urology · 18d
Cleared Feb 17, 2012
CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM
K120321 · IYN
Philips Health Care
Radiology · 15d
Cleared Feb 16, 2012
EAUM TOTAL KNEE SYSTEM
K110404 · JWH
Corentec Co., Ltd.
Orthopedic · 367d
Cleared Feb 16, 2012
PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS...
K110825 · MKJ
Philips Medical Systems
Cardiovascular · 330d
Cleared Feb 16, 2012
ICON (TM) MODULAR PEDICLE SCREW SYSTEM
K111448 · NKB
Orthofix, Inc.
Orthopedic · 268d
Cleared Feb 16, 2012
UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
K111473 · CBK
Impact Instrumentation, Inc.
Anesthesiology · 265d
Cleared Feb 16, 2012
WAVES
K111521 · KDN
Waters Medical Systems, LLC
Gastroenterology & Urology · 260d