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

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176,076 results
70153–70176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 2004
SEDLINE WITH FRONTAL PSI
K033999 · OLW
Physiometrix, Inc.
Neurology · 44d
Cleared Feb 06, 2004
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR...
K034060 · LYZ
Hong Huang Tang Industrial Co., Ltd.
General Hospital · 37d
Cleared Feb 06, 2004
ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE
K040142 · LLZ
Adac Laboratories
Radiology · 15d
Cleared Feb 05, 2004
40 L HIGH FLOW INSUFFLATOR F108
K030837 · HIF
W.O.M. World of Medicine AG
Obstetrics & Gynecology · 325d
Cleared Feb 05, 2004
TRIMED RADIAL BULLET
K030877 · HRS
Tri-Med, Inc.
Orthopedic · 322d
Cleared Feb 05, 2004
QCA (VERSION 3.1)
K031363 · NQN
Cell Analysis, Inc.
Pathology · 281d
Cleared Feb 05, 2004
MOSSMED DUAL INTERMITTENT ASPIRATOR
K031492 · KNT
Moss Medical Products
Gastroenterology & Urology · 269d
Cleared Feb 05, 2004
VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN
K032416 · EIH
Shofu Dental Corp.
Dental · 184d
Cleared Feb 05, 2004
INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)
K032631 · FYA
Lac Mac, Ltd.
General Hospital · 163d
Cleared Feb 05, 2004
HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM
K033089 · GEI
Gyrus Ent LLC
General & Plastic Surgery · 129d
Cleared Feb 05, 2004
DEPUY SIGMA TIBIAL INSERTS
K033272 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 118d
Cleared Feb 05, 2004
SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
K033382 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 105d
Cleared Feb 05, 2004
HEARTRAK SMART AT/HEARTRAK SMART2
K033451 · DXH
Universal Medical, Inc.
Cardiovascular · 98d
Cleared Feb 05, 2004
INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER
K033527 · DYB
B.Braun Medical, Inc.
Cardiovascular · 90d
Cleared Feb 05, 2004
SMARTSET GHV GENTAMICIN BONE CEMENT
K033563 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Feb 05, 2004
SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM
K033618 · HSB
Synthes (Usa)
Orthopedic · 79d
Cleared Feb 05, 2004
AEGIS PIT & FISSURE SEALANT WITH ACP
K033751 · EBC
Harry J. Bosworth Co.
Dental · 66d
Cleared Feb 05, 2004
ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K033777 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 63d
Cleared Feb 05, 2004
SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM
K033844 · KWQ
Synthes (Usa)
Orthopedic · 56d
Cleared Feb 05, 2004
MODIFICATION TO DIADEXUS PLAC TEST
K040101 · NOE
Diadexus, Inc.
Chemistry · 16d
Cleared Feb 04, 2004
APEX MEDICAL CPAP RT 21XX
K022650 · BZD
Apex Medical Corp.
Anesthesiology · 544d
Cleared Feb 04, 2004
AMSURE RED RUBBER URETHRAL CATHETER
K030293 · EYB
Amsino International, Inc.
Gastroenterology & Urology · 372d
Cleared Feb 04, 2004
BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM
K032216 · NHN
Bioptron AG
Physical Medicine · 198d
Cleared Feb 04, 2004
DURAMAX .018 BILIARY STENT SYSTEM
K032436 · FGE
Avantec Vascular Corp.
Gastroenterology & Urology · 181d