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

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175,820 results
49993–50016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 2010
HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS
K101570 · MJN
Micro Therapeutics Dba Ev3 Neurovascular
Cardiovascular · 39d
Cleared Jul 13, 2010
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA...
K101703 · DSI
Card Guard Scientific Survival , Ltd.
Cardiovascular · 26d
Cleared Jul 12, 2010
IMPROVACUTER GEL & CLOT ACTIVATOR TUBE
K093910 · JKA
Guangzhou Improve Medical Instruments...
Chemistry · 202d
Cleared Jul 12, 2010
VARIAN TREATMENT
K093967 · IYE
Varian Medical Systems, Inc.
Radiology · 201d
Cleared Jul 12, 2010
EMBO PLUS EMBOLECTOMY CATHETER
K100840 · DXE
Hotspur Technologies
Cardiovascular · 110d
Cleared Jul 12, 2010
PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM
K100842 · DXE
Hotspur Technologies
Cardiovascular · 109d
Cleared Jul 12, 2010
ASCENSION ANKLE FUSION NAIL SYSTEM
K100925 · HSB
Ascension Orthopedics, Inc.
Orthopedic · 101d
Cleared Jul 12, 2010
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE
K101059 · LCM
Omega Laboratories, Inc.
Toxicology · 88d
Cleared Jul 12, 2010
SAVI PREPARATION DEVICE
K101411 · JAQ
Cianna Medical, Inc.
Radiology · 54d
Cleared Jul 09, 2010
SECURACATH UNIVERSAL
K092306 · LJS
Interrad Medical, Inc.
General Hospital · 345d
Cleared Jul 09, 2010
NIHON KOHDEN QP-160AK EEG TREND PROGRAM
K092573 · OMA
Nihon Kohden America, Inc.
Neurology · 323d
Cleared Jul 09, 2010
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM
K092853 · MLO
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 296d
Cleared Jul 09, 2010
VENOFER PUMP
K093964 · KDI
Renal Solutions, Inc.
Gastroenterology & Urology · 197d
Cleared Jul 09, 2010
FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM
K100405 · CGA
Taidoc Technology Corporation
Chemistry · 143d
Cleared Jul 09, 2010
MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER
K100428 · DQA
Masimo Corporation
Anesthesiology · 143d
Cleared Jul 09, 2010
POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L...
K100432 · FPA
Medtronic Minimed
General Hospital · 143d
Cleared Jul 09, 2010
CLAVE NEUTRON
K100434 · FPA
Icu Medical, Inc.
General Hospital · 143d
Cleared Jul 09, 2010
COTEC DENTAL IMPLANT SYSTEM
K100511 · DZE
Cotec Implant Co., Ltd.
Dental · 137d
Cleared Jul 09, 2010
ECLERIS MICROSTAR COLPOSCOPE
K100595 · HEX
Ecleris USA
Obstetrics & Gynecology · 129d
Cleared Jul 09, 2010
PROSTHODONTIC SCREWDRIVER , MODEL IA-400
K100600 · EKX
W&H Dentalwerk Buermoos GmbH
Dental · 128d
Cleared Jul 09, 2010
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM,...
K100647 · ELC
A-Dec, Inc.
Dental · 123d
Cleared Jul 09, 2010
U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM
K100658 · DXN
Taidoc Technology Corporation
Cardiovascular · 123d
Cleared Jul 09, 2010
FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
K100732 · NBW
Taidoc Technology Corporation
Chemistry · 116d
Cleared Jul 09, 2010
MD2000B VITAL SIGN MONITOR, MODEL MD2000B
K100740 · MWI
Beijing Choice Electronic Technololgy...
Cardiovascular · 115d