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
53065–53088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 2009
VAKU-8 BLOOD COLLECTION NEEDLES
K090426 · FMI
Myco Medical Supplies, Inc.
General Hospital · 113d
Cleared Jun 12, 2009
QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL...
K090511 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 106d
Cleared Jun 12, 2009
AIRWAY BALLOON CATHETER INFLATION DEVICE
K090660 · KTI
Acclarent, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 12, 2009
STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING...
K090929 · FMF
Shanghai Double Dove Industrial Co.,...
General Hospital · 71d
Cleared Jun 12, 2009
TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM...
K090961 · LXC
Twin Star Medical, Inc.
Orthopedic · 67d
Cleared Jun 12, 2009
FLOCONTROL , MODEL 1028
K090970 · MJN
Coaxia, Inc.
Cardiovascular · 67d
Cleared Jun 12, 2009
DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS
K090998 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 65d
Cleared Jun 12, 2009
BLUEPHASE 20I
K091020 · EBZ
Ivoclar Vivadent, Inc.
Dental · 64d
Cleared Jun 12, 2009
LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS
K091181 · MRZ
Smiths Medical MD, Inc.
General Hospital · 50d
Cleared Jun 12, 2009
GOPHER GOLD CATHETER, MODEL 5620
K091345 · DQY
Vascular Solutions, Inc.
Cardiovascular · 37d
Cleared Jun 12, 2009
XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01
K091432 · GAT
Anulex Technologies, Inc.
General & Plastic Surgery · 29d
Cleared Jun 12, 2009
ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER
K091527 · DQY
Cook, Inc.
Cardiovascular · 17d
Cleared Jun 12, 2009
CUSTOM COMFORT NIGHTGUARD VERSION 2
K091660 · OBR
Den Tek Oral Care, Inc.
Dental · 3d
Cleared Jun 11, 2009
BAIXIN INTRAVASCULAR ADMINISTRATION SET
K083687 · FPA
Anhui Kangda Medical Products Co., Ltd.
General Hospital · 181d
Cleared Jun 11, 2009
DISPOSABLE INFUSION SET
K090012 · FPA
Shan Dong Wei Gao Group Medical...
General Hospital · 160d
Cleared Jun 11, 2009
PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D
K090671 · DQA
Contec Medical System Co., Ltd.
Anesthesiology · 90d
Cleared Jun 11, 2009
PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER
K090767 · MRW
Interventional Spine, Inc.
Orthopedic · 80d
Cleared Jun 11, 2009
MODIFICATION TO AVIE A1C TEST SYSTEM
K091400 · LCP
Mec Dynamics Corp
Chemistry · 30d
Cleared Jun 11, 2009
FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES
K091490 · FER
Thd Spa
Gastroenterology & Urology · 22d
Cleared Jun 10, 2009
COOLSKIN
K083008 · ILO
Elbio Co., Ltd.
Physical Medicine · 245d
Cleared Jun 10, 2009
SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT...
K083010 · DQA
Shenzhen Med-Link Electronics Tech...
Anesthesiology · 244d
Cleared Jun 10, 2009
HABIB ENDOHPB
K083292 · KNS
Emcision , Ltd.
Gastroenterology & Urology · 212d
Cleared Jun 10, 2009
STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM
K090093 · GKR
Stanbio Laboratory
Hematology · 147d
Cleared Jun 10, 2009
TRIOS SYSTEM
K090399 · ONF
Viora , Ltd.
General & Plastic Surgery · 113d