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
41449–41472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 2013
ISO-GARD CLEARAIR MASK
K123176 · CBN
Teleflexmedical, Inc.
Anesthesiology · 127d
Cleared Feb 14, 2013
A5 ANESTHESIA DELIVERY SYSTEM
K123211 · BSZ
Datascope Corp., Patient Monitoring...
Anesthesiology · 125d
Cleared Feb 14, 2013
EQUAFLOW MULTIVALVE INFUSION CATHETER
K123235 · DYB
Cook Incorporated
Cardiovascular · 121d
Cleared Feb 14, 2013
SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT
K123240 · MBI
ArthroCare Corporation
Orthopedic · 121d
Cleared Feb 14, 2013
ILLICO MIS POSTERIOR FIXATION SYSTEM
K123623 · NKB
Alphatec Spine, Inc.
Orthopedic · 83d
Cleared Feb 14, 2013
CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE
K123647 · JOW
Devon Medical, Inc.
Cardiovascular · 79d
Cleared Feb 14, 2013
VITRO MOLAR
K123826 · EMA
Dfl Industria E Comercio SA
Dental · 64d
Cleared Feb 14, 2013
CONNECT FOR DA VINCI SURGICAL SYSTEM(S)
K123840 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 63d
Cleared Feb 14, 2013
GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK
K123851 · JJX
Bionostics, Inc.
Chemistry · 62d
Cleared Feb 14, 2013
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM
K123918 · HRS
Zimmer, Inc.
Orthopedic · 57d
Cleared Feb 14, 2013
MONOJECT 12ML SYRINGE
K130049 · FMF
Nipro Medical Corporation
General Hospital · 37d
Cleared Feb 14, 2013
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP
K130055 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 36d
Cleared Feb 13, 2013
TRANSFERRIN KIT FOR USE ON THE SPAPLUS
K120236 · DDG
The Binding Site Group , Ltd.
Immunology · 384d
Cleared Feb 13, 2013
INTEGRA PROXIMAL HUMERAL PLATE SYSTEM
K121826 · HRS
Ascension Orthopedics, Inc.
Orthopedic · 237d
Cleared Feb 13, 2013
DOSE TRACKING SYSTEM MODEL XIDF-DTS801
K123097 · JAA
Toshiba America Medical Systems, In.C
Radiology · 134d
Cleared Feb 13, 2013
ULTRASOUND SCANNER FLEX FOCUS
K123254 · IYN
B-K Medical Aps
Radiology · 118d
Cleared Feb 13, 2013
RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS
K123412 · OSH
K2m, Inc.
Orthopedic · 99d
Cleared Feb 13, 2013
MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
K123524 · JXG
Medtronic Neurosurgery
Neurology · 90d
Cleared Feb 12, 2013
FORYOU NPWT DEVICE
K113236 · OMP
Foryou Medical Electronics Co, Ltd.
General & Plastic Surgery · 468d
Cleared Feb 12, 2013
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K113614 · NBW
Roche Diagnostics
Chemistry · 434d
Cleared Feb 12, 2013
MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
K120663 · MYA
Dako North America, Inc.
Pathology · 344d
Cleared Feb 12, 2013
GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM...
K121877 · KWP
Exactech, Inc.
Orthopedic · 229d
Cleared Feb 12, 2013
NEW STETIC ARTIFICIAL TEETH
K122925 · ELM
New Stetic
Dental · 141d
Cleared Feb 12, 2013
RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
K123544 · LIT
Ev3, Inc.
Cardiovascular · 85d