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
71473–71496 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 2003
BEELINE SYSTEM
K032642 · FRN
Mckinley, Inc.
General Hospital · 27d
Cleared Sep 23, 2003
CONTOUR SE MICROSPHERES (SYRINGE)
K032707 · HCG
Boston Scientific Corp
Neurology · 21d
Cleared Sep 23, 2003
MODULAR PLUS HIP STEM
K032709 · LWJ
Plus Orthopedics
Orthopedic · 21d
Cleared Sep 23, 2003
EYESOPEN TONOMETER
K032769 · HKY
Eye-Deas, LLC
Ophthalmic · 15d
Cleared Sep 23, 2003
MEDRAD CONTINUUM MR INFUSION SYSTEM
K032771 · FRN
Medrad, Inc.
General Hospital · 15d
Cleared Sep 23, 2003
DIAMOND D HIGH IMPACT DENTURE ACRYLIC
K032773 · EBI
Mycone Dental Supply Co., Inc.
Dental · 15d
Cleared Sep 23, 2003
MYOSYSTEM WITH CUSTOMIZING
K032833 · GXY
Otto Bock Healthcare LP
Neurology · 12d
Cleared Sep 22, 2003
MODIFICATION TO HIGHGATE CURVED ROD SYSTEM
K023983 · KWQ
Highgate Orthopaedics
Orthopedic · 294d
Cleared Sep 22, 2003
HALM ZIELKE INSTRUMENTATION SYSTEM
K024125 · KWQ
Micomed Ortho GmbH
Orthopedic · 280d
Cleared Sep 22, 2003
ESKA MODULAR HIP SYSTEM CEMENTED
K030867 · JDI
Eska Implants GmbH
Orthopedic · 187d
Cleared Sep 22, 2003
ULTRA-DRIVE 3
K031280 · JDX
Biomet, Inc.
Neurology · 153d
Cleared Sep 22, 2003
GLYCOMARK
K031604 · NOZ
Tomen America, Inc.
Chemistry · 123d
Cleared Sep 22, 2003
ALEXIS WOUND RETRACTOR
K031889 · KKX
Applied Medical Resources Corp.
General Hospital · 96d
Cleared Sep 22, 2003
ARTHREX TRIMIT SCREW, MODEL AR-4161B
K031945 · HWC
Arthrex, Inc.
Orthopedic · 90d
Cleared Sep 22, 2003
MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET
K031955 · FTL
Macropore Biosurgery, Inc.
General & Plastic Surgery · 89d
Cleared Sep 22, 2003
MEDLINE BAND BAGS AND EQUIPMENT COVERS
K032065 · MMP
Medline Industries, Inc.
General Hospital · 81d
Cleared Sep 22, 2003
PROCLASS PRESS FIT HIP STEM
K032110 · LWJ
Stelkast Company
Orthopedic · 75d
Cleared Sep 22, 2003
CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)
K032169 · LXT
Cyberorthology, Inc.
Orthopedic · 68d
Cleared Sep 22, 2003
ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM
K032187 · HRS
Arthrex, Inc.
Orthopedic · 67d
Cleared Sep 22, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML
K032299 · LON
Becton, Dickinson & CO
Microbiology · 59d
Cleared Sep 22, 2003
WAGNER CONE PROSTHESIS
K032380 · LZO
Centerpulse Orthopedics, Inc.
Orthopedic · 52d
Cleared Sep 22, 2003
ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST
K032510 · LCX
ACON Laboratories, Inc.
Chemistry · 39d
Cleared Sep 22, 2003
LARGE VOLUME FLUID RESERVOIR
K032778 · LGZ
Belmont Instrument Corp.
General Hospital · 14d
Cleared Sep 17, 2003
BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)
K023758 · OKS
Fci Ophthalmics, Inc.
Ophthalmic · 313d