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
75529–75552 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2002
PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC...
K022303 · IYN
Philips Ultrasound, Inc.
Radiology · 14d
Cleared Jul 30, 2002
QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61
K022355 · DIO
Branan Medical Corp.
Toxicology · 11d
Cleared Jul 29, 2002
REPROCESSED TROCARS AND CANNULAS
K012644 · NLM
Surgical Instruments Service and...
Gastroenterology & Urology · 350d
Cleared Jul 29, 2002
FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST
K013263 · LKP
Fred Hutchinson Cancer Research Center
Immunology · 301d
Cleared Jul 29, 2002
WISORB MALLEOLAR SCREW
K020222 · HWC
Cambridge Scientific, Inc.
Orthopedic · 188d
Cleared Jul 29, 2002
READI-STRAND
K020337 · KXK
Worldwide Medical Technologies, LLC
Radiology · 178d
Cleared Jul 29, 2002
MICROPLEX COIL SYSTEM (MCS)
K020434 · HCG
MicroVention, Inc.
Neurology · 171d
Cleared Jul 29, 2002
ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE
K020657 · NHN
Acculaser, Inc.
Physical Medicine · 151d
Cleared Jul 29, 2002
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
K021194 · DCK
Hemagen Diagnostics, Inc.
Chemistry · 105d
Cleared Jul 29, 2002
RESORBABLE CRANIAL CLAMPS
K021408 · GXR
Synthes (Usa)
Neurology · 87d
Cleared Jul 29, 2002
HERPESELECT 1 ELISA IGG, MODEL EL0910G
K021429 · MXJ
Focus Technologies, Inc.
Microbiology · 87d
Cleared Jul 29, 2002
MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K021604 · HBL
Ohio Medical Instrument Co., Inc.
Neurology · 74d
Cleared Jul 29, 2002
CODMAN BACTISEAL EVD CATHETER SET
K021653 · JXG
Codman & Shurtleff, Inc.
Neurology · 70d
Cleared Jul 29, 2002
CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET
K021757 · DCN
Good Biotech Corp.
Immunology · 61d
Cleared Jul 29, 2002
ADVANTAGE SIM 6.0
K021780 · KPQ
General Electric Medical Systems
Radiology · 60d
Cleared Jul 29, 2002
ADMIRA SEAL
K021842 · EBC
Voco GmbH
Dental · 54d
Cleared Jul 29, 2002
ENDIUS TITLE SPINAL FIXATION SYSTEM
K021881 · MNH
Endius, Inc.
Orthopedic · 52d
Cleared Jul 29, 2002
PSG INPUT BOX, MODEL JE-912AK
K022121 · OLV
Nihon Kohden America, Inc.
Neurology · 28d
Cleared Jul 29, 2002
BD VACUTAINER PLUS PST II TUBE
K022130 · JKA
Becton, Dickinson & CO
Chemistry · 28d
Cleared Jul 29, 2002
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K022161 · GKZ
Beckman Coulter, Inc.
Hematology · 26d
Cleared Jul 29, 2002
MODIFICATION TO CARDEON AEGIS CATHETER
K022174 · DWF
Cardeon Corp.
Cardiovascular · 26d
Cleared Jul 29, 2002
PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120
K022200 · GKZ
Abx Diagnostics
Hematology · 24d
Cleared Jul 26, 2002
ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER
K011329 · BXQ
E. Benson Hood Lab, Inc.
Anesthesiology · 451d
Cleared Jul 26, 2002
SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
K020882 · LZU
Surgical Specialties Corp
Ophthalmic · 130d