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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
63985–64008 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 2005
BP PRO BLOOD PRESSURE MONITOR
K053395 · DXN
Card Guard Scientific Survival , Ltd.
Cardiovascular · 17d
Cleared Dec 22, 2005
LIFEPAK, MODEL 1000
K042404 · MKJ
Medtronic Emergency Response Systems,...
Cardiovascular · 475d
Cleared Dec 22, 2005
CHEMPAQ XBC ANALYZER
K050758 · GKZ
Chempaq A/S
Hematology · 274d
Cleared Dec 22, 2005
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
K050843 · JAD
Xoft, Inc.
Radiology · 265d
Cleared Dec 22, 2005
ADULT CEREBRAL OXIMETER, MODEL 2040
K051257 · DQA
Cas Medical Systems, Inc.
Anesthesiology · 220d
Cleared Dec 22, 2005
DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE
K051487 · KHJ
Doctor'S Research Group, Inc.
Ear, Nose, Throat · 199d
Cleared Dec 22, 2005
ZAN LUNG-FUNCTION LAB
K052328 · BZC
Zan Messgerate GmbH
Anesthesiology · 119d
Cleared Dec 22, 2005
CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)
K052397 · MEG
Life-Shield Products, Inc.
General Hospital · 113d
Cleared Dec 22, 2005
NITOM LOCKING FACEBOW
K052553 · DZB
Russell Samuels Orthodontic Design
Dental · 97d
Cleared Dec 22, 2005
CALM CURVE, VERSION 01.00
K052715 · HGM
Lms Medical Systems (Canada), Ltd.
Obstetrics & Gynecology · 84d
Cleared Dec 22, 2005
ALMITECH INC. DENTAL IMPLANT SYSTEM
K052733 · DZE
Almitech, Inc.
Dental · 84d
Cleared Dec 22, 2005
DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
K052743 · CBP
Dynarex Corp.
Anesthesiology · 83d
Cleared Dec 22, 2005
TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE
K052846 · MQX
Maanshan Medical Instruments Co., Ltd.
General Hospital · 76d
Cleared Dec 22, 2005
TYRX SURGICAL MESH, MODEL SMPC-0501
K052864 · FTL
Tyrx Pharma, Inc.
General & Plastic Surgery · 72d
Cleared Dec 22, 2005
HOSPIRA CATH LAB CONVENIENCE KITS
K052865 · DQO
Icu Medical, Inc.
Cardiovascular · 72d
Cleared Dec 22, 2005
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
K053051 · KTT
Vanguard Medical Concepts, Inc.
Orthopedic · 55d
Cleared Dec 22, 2005
ORTHODONTIC POLYMER COMPOSITE BRACKET
K053055 · DYW
Gestenco International AB
Dental · 52d
Cleared Dec 22, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML
K053241 · LON
Becton, Dickinson & CO
Microbiology · 34d
Cleared Dec 22, 2005
UROVANTAGE
K053279 · OWB
Pck Electronic Industry & Trade Co.,...
Radiology · 29d
Cleared Dec 22, 2005
MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION
K053286 · KPO
Nxstage Medical, Inc.
Gastroenterology & Urology · 27d
Cleared Dec 22, 2005
MEDILOG DARWIN HOLTER ANALYSIS
K053369 · DQK
Huntleigh Healthcare
Cardiovascular · 17d
Cleared Dec 22, 2005
NEXA BONE PLATE AND SCREW SYSTEM
K053408 · HRS
Nexa Orthopedics, Inc.
Orthopedic · 15d
Cleared Dec 22, 2005
WEB1000
K053458 · LLZ
Agfa Corp.
Radiology · 9d
Cleared Dec 21, 2005
FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1
K051294 · HHK
Femspec LLC
Obstetrics & Gynecology · 217d