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
61297–61320 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 2006
STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED
K062778 · LZA
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 39d
Cleared Oct 27, 2006
MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A
K062860 · LNH
Neusoft Medical Systems Co., Ltd.
Radiology · 32d
Cleared Oct 27, 2006
MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML)
K063065 · LRG
Dade Behring, Inc.
Microbiology · 21d
Cleared Oct 27, 2006
3DNET SUITE
K063107 · LLZ
Biotronics3D, Ltd.
Radiology · 16d
Cleared Oct 27, 2006
EP-WORKMATE
K063113 · DQK
Ep Medsystems
Cardiovascular · 16d
Cleared Oct 26, 2006
SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200
K052055 · LGZ
Smisson-Cartledge Biomedical, LLC
General Hospital · 454d
Cleared Oct 26, 2006
NEOTRACT ANCHOR
K061700 · GAW
Neotract, Inc.
General & Plastic Surgery · 132d
Cleared Oct 26, 2006
STRYKER ARIA PNEUMATIC SYSTEM
K061725 · HBB
Stryker Instruments
Neurology · 129d
Cleared Oct 26, 2006
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
K061899 · FEB
Advanced Sterilization Products
General Hospital · 115d
Cleared Oct 26, 2006
OSTEOBOOST-BMA
K062260 · FMF
Orthos Limited
General Hospital · 83d
Cleared Oct 26, 2006
MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML)
K062375 · LRG
Dade Behring, Inc.
Microbiology · 72d
Cleared Oct 26, 2006
ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF
K062471 · LFL
Misonix, Inc.
General & Plastic Surgery · 63d
Cleared Oct 26, 2006
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
K062699 · FRN
B.Braun Medical, Inc.
General Hospital · 45d
Cleared Oct 26, 2006
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
K062700 · FRN
B.Braun Medical, Inc.
General Hospital · 45d
Cleared Oct 26, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062783 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 38d
Cleared Oct 26, 2006
MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F
K062887 · DTK
Bard Peripheral Vascular
Cardiovascular · 30d
Cleared Oct 26, 2006
MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML)
K063053 · LRG
Dade Behring, Inc.
Microbiology · 22d
Cleared Oct 26, 2006
MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML)
K063064 · LRG
Dade Behring, Inc.
Microbiology · 20d
Cleared Oct 26, 2006
CST61 HIGH SPEED TURBINE HANDPIECE
K063110 · EFB
Shanghai Dental Instrument Factory
Dental · 15d
Cleared Oct 25, 2006
AMBU WHITE SENSOR CFM, CFL
K052944 · DRX
Ambu A/S
Cardiovascular · 370d
Cleared Oct 25, 2006
AMBU BLUE SENSOR NEO AND NEO X
K053550 · DRX
Ambu A/S
Cardiovascular · 309d
Cleared Oct 25, 2006
REMCORE REMOTE CONTROLLED OXYGEN REGULATOR
K060265 · CAN
Remcore, Inc.
Anesthesiology · 266d
Cleared Oct 25, 2006
CD HORIZON SPINAL SYSTEM
K060615 · NKB
Medtronic Sofamor Danek
Orthopedic · 232d
Cleared Oct 25, 2006
MALIBU SPINAL SYSTEM
K061342 · NKB
Seaspine, Inc.
Orthopedic · 193d