Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
52633–52656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 2009
GLUCOMANAGER DATA MANAGEMENT SOFTWARE
K091229 · NBW
Eps Bio Technology Corp.
Chemistry · 95d
Cleared Jul 31, 2009
HERO VASCULAR ACCESS DEVICE
K091491 · DSY
Hemosphere, Inc.
Cardiovascular · 72d
Cleared Jul 31, 2009
FLEXITIME FLOW
K091494 · ELW
Heraeus Kulzer, Inc.
Dental · 72d
Cleared CT Jul 31, 2009
MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556
K091500 · DXN
Andon Health Co, Ltd.
Cardiovascular · 71d
Cleared Jul 31, 2009
SOFTLASE PRO, ORTHOLASE AND HYGIENELASE
K091796 · GEX
Zap Lasers, LLC
General & Plastic Surgery · 44d
Cleared Jul 31, 2009
RAPID PROGRAMMER, VERSION 3.3.0
K091993 · GZB
Advanced Neuromodulation Systems,...
Neurology · 29d
Cleared Jul 30, 2009
MEDOS HILITE RESERVOIR, MODEL: 4030
K083131 · DTN
Gish Biomedical, Inc.
Cardiovascular · 280d
Cleared Jul 30, 2009
ELASTO-GEL MANUKA HONEY WOUND DRESSING
K083334 · FRO
Southwest Technologies, Inc.
General & Plastic Surgery · 260d
Cleared Jul 30, 2009
LNCS OXIMETRY SENSORS
K083719 · NLF
Masimo Corporation
Anesthesiology · 227d
Cleared Jul 30, 2009
EXSALT SD7 WOUND DRESSING
K083870 · FRO
Exciton Technologies, Inc.
General & Plastic Surgery · 213d
Cleared Jul 30, 2009
5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS
K090203 · NKB
Ebi, L.P.
Orthopedic · 184d
Cleared Jul 30, 2009
FORTEX PEDICLE SCREW SYSTEM
K090224 · MNH
X-Spine Systems, Inc.
Orthopedic · 181d
Cleared Jul 30, 2009
THERAFORM STANDARD/SHEET
K090812 · KGN
Sewon Cellontech Co., Ltd.
General & Plastic Surgery · 127d
Cleared Jul 30, 2009
BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS
K090844 · DJG
Lin-Zhi International, Inc.
Toxicology · 125d
Cleared Jul 30, 2009
ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE
K090850 · LYC
Apatech , Ltd.
Dental · 122d
Cleared Jul 30, 2009
AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL...
K090867 · DYB
Ep Dynamics, Inc.
Cardiovascular · 121d
Cleared Jul 30, 2009
NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER
K090918 · DQY
Nfocus Neuromedical, Inc.
Cardiovascular · 120d
Cleared Jul 30, 2009
ATLAS WOUND MATRIX
K090954 · KGN
Wrightmedicaltechnologyinc
General & Plastic Surgery · 115d
Cleared Jul 30, 2009
SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND
K091013 · FRO
Advanced Medical Solutions Limited
General & Plastic Surgery · 112d
Cleared Jul 30, 2009
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
K091190 · JDQ
Zimmer Spine, Inc.
Orthopedic · 98d
Cleared Jul 30, 2009
MANTRA COMBO, MODEL MECS 320
K091236 · GZJ
Mantra Intl. (Hk) , Ltd.
Neurology · 94d
Cleared Jul 30, 2009
CORDCAP
K091380 · MVL
Centrix, Inc.
Dental · 80d
Cleared Jul 30, 2009
HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2
K091390 · OAT
Hdc S.R.L.
Dental · 80d
Cleared Jul 30, 2009
TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK
K091392 · NHA
Pou YU Biotechnology Co., Ltd.
Dental · 80d