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
79609–79632 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 2001
PROACT 1
K003909 · IRP
Proact Co.
Physical Medicine · 176d
Cleared Jun 13, 2001
AVIATOR PERIPHERAL DILATATION CATHETER
K010831 · DQY
Guidant Corp.
Cardiovascular · 85d
Cleared Jun 13, 2001
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN)
K010854 · LYY
Protection Gloves Sdn. Bhd.
General Hospital · 83d
Cleared Jun 13, 2001
PLLA PIN
K010983 · HTY
Bionx Implants, Inc.
Orthopedic · 72d
Cleared Jun 13, 2001
LUNAPADS
K010986 · NUQ
Lunapads International Products, Ltd.
Obstetrics & Gynecology · 72d
Cleared Jun 13, 2001
FORTADERM WOUND DRESSING
K011026 · KGN
Organogenesis, Inc.
General & Plastic Surgery · 70d
Cleared Jun 13, 2001
MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM
K011095 · IYO
Iodp SA
Radiology · 64d
Cleared Jun 13, 2001
BD SPRING BASED SYRINGE
K011103 · MEG
Bd
General Hospital · 63d
Cleared Jun 13, 2001
HYDRAGEL ISO-PAL K20 (PN 3022)
K011113 · CIN
Sebia
Chemistry · 63d
Cleared Jun 13, 2001
NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL...
K011125 · CAT
Hudson Respiratory Care, Inc.
Anesthesiology · 61d
Cleared Jun 13, 2001
OXYGEN SUPPLY TUBING, MODEL 1115
K011134 · BYX
Hudson Respiratory Care, Inc.
Anesthesiology · 61d
Cleared Jun 13, 2001
ULTRACONCENTRATOR SYSTEM
K011148 · FJI
Interpore Cross Intl.
Gastroenterology & Urology · 58d
Cleared Jun 13, 2001
CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN
K011231 · LYY
Protection Gloves Sdn. Bhd.
General Hospital · 51d
Cleared Jun 13, 2001
BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...
K011234 · LPL
American Biocurve, Inc.
Ophthalmic · 51d
Cleared Jun 13, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K011250 · JJX
Ortho-Clinical Diagnostics, Inc.
Microbiology · 50d
Cleared Jun 13, 2001
BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...
K011316 · LPL
American Contact Lens, Inc.
Ophthalmic · 44d
Cleared Jun 13, 2001
HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883
K011384 · JTN
Hardy Diagnostics
Microbiology · 37d
Cleared Jun 13, 2001
SELF-ADHESIVE ELECTRODES
K011411 · GXY
Pain Management Technologies
Neurology · 36d
Cleared Jun 13, 2001
SILICONE IMPRESSION MATERIAL
K011450 · ELW
Northeast Resins & Silicones, LLC
Dental · 33d
Cleared Jun 13, 2001
OIL FOR TISSUE CULTURE
K011462 · MQL
Conception Technologies
Obstetrics & Gynecology · 30d
Cleared Jun 13, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS
K011463 · JJX
Ortho-Clinical Diagnostics
Chemistry · 30d
Cleared Jun 13, 2001
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL...
K011464 · DQY
Vascular Intervention
Cardiovascular · 30d
Cleared Jun 13, 2001
BARRETT UNICONDYLAR TIBIAL BEARING
K011509 · HRY
Biomet, Inc.
Orthopedic · 28d
Cleared Jun 13, 2001
FAST THERMOMETER MODELS ST713C AND ST713F
K011585 · FLL
Mesure Technology
General Hospital · 21d