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
66337–66360 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 2005
HL168JP
K050249 · DXN
Health & Life Co., Ltd.
Cardiovascular · 55d
Cleared Mar 30, 2005
POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN
K050467 · LZA
Shen Wei (Usa), Inc.
General Hospital · 35d
Cleared Mar 30, 2005
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
K050577 · DQO
Boston Scientific Corp
Cardiovascular · 23d
Cleared Mar 30, 2005
SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS
K050670 · DXH
Tms Telemedizinische Systeme GmbH
Cardiovascular · 15d
Cleared Mar 30, 2005
MODIFICATION TO:ZILVER 518 BILIARY STENT
K050698 · FGE
Cook, Inc.
Gastroenterology & Urology · 13d
Cleared Mar 30, 2005
MINIMASTER ULTRASONIC SCALER
K050710 · ELC
E.M.S Electro Medical Systems S.A
Dental · 12d
Cleared Mar 29, 2005
NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
K042384 · GZL
Cyberkinetics, Inc. (Cki)
Neurology · 209d
Cleared Mar 29, 2005
MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C
K043600 · FRN
Medtronic Minimed
General Hospital · 90d
Cleared Mar 29, 2005
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN
K050043 · LRG
Dade Behring, Inc.
Microbiology · 78d
Cleared Mar 29, 2005
PREGNANCY-SKREEN
K050328 · JJX
Biochemical Diagnostic, Inc.
Chemistry · 48d
Cleared Mar 29, 2005
IMPLANT LOCATION SOFTWARE, MODEL 0.1.0
K050341 · LLZ
Tactile Technologies, Ltd.
Radiology · 46d
Cleared Mar 29, 2005
CIE FOLDAWAY WHEELCHAIR
K050345 · IOR
Carlsbad International Export, Inc.
Physical Medicine · 46d
Cleared Mar 29, 2005
OSSAPLAST ORTHO
K050416 · MQV
Ossacur AG
Orthopedic · 39d
Cleared Mar 29, 2005
SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES
K050455 · LYZ
Zibo Blue Intco Plastic & Rubber...
General Hospital · 35d
Cleared Mar 29, 2005
SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT
K050539 · JWH
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Mar 29, 2005
EKOS PERIPHERAL INFUSION SYSTEM
K050563 · QEY
Ekos Corp.
Cardiovascular · 25d
Cleared Mar 29, 2005
R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE
K050667 · LLZ
R2 Technology, Inc.
Radiology · 14d
Cleared Mar 28, 2005
NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM
K042626 · GWQ
Cyberkinetics, Inc.
Neurology · 182d
Cleared Mar 28, 2005
SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT
K043556 · JXM
Beckman Coulter, Inc.
Chemistry · 91d
Cleared Mar 28, 2005
FRESHLOOK ONE-DAY COLOR CONTACT LENS
K050213 · MVN
Ciba Vision Corporation
Ophthalmic · 56d
Cleared Mar 28, 2005
PACHPEN PACHYMETER, MODEL 24-5100
K050552 · IYO
Accutome, Inc.
Radiology · 25d
Cleared Mar 28, 2005
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D,...
K050623 · HJK
Volk Optical, Inc.
Ophthalmic · 18d
Cleared Mar 25, 2005
DYNAGRAFT II
K040419 · MQV
Isotis Orthobiologics, Inc.
Orthopedic · 401d
Cleared Mar 25, 2005
ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100
K041881 · CGA
Hypoguard USA, Inc.
Chemistry · 256d