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

Filters: Cleared only ×
176,076 results
79273–79296 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 2001
BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER
K011455 · JDI
Biomet, Inc.
Orthopedic · 68d
Cleared Jul 18, 2001
UROLOGICAL CATHETER
K011552 · GBM
Apogee Medical, Inc.
Gastroenterology & Urology · 61d
Cleared Jul 18, 2001
ADMIRA FLOW
K011756 · EBF
Voco GmbH
Dental · 42d
Cleared Jul 18, 2001
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K011881 · FGE
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared Jul 18, 2001
OIL FOR EMBRYO CULTURE
K011938 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 27d
Cleared Jul 18, 2001
IVENT 201 PORTABLE VENTILATOR
K011957 · CBK
Versamed , Ltd.
Anesthesiology · 26d
Cleared Jul 18, 2001
1.5MM BONE FIXATION KIT
K012000 · HWC
Bionx Implants, Ltd.
Orthopedic · 21d
Cleared Jul 18, 2001
SMARTSCREW
K012001 · HWC
Bionx Implants, Ltd.
Orthopedic · 21d
Cleared Jul 18, 2001
TRIDENT ALL POLY CUP
K012026 · JDI
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Jul 17, 2001
WUNDCATH CONDUCTION CATHETER
K003966 · FRN
Micor, Inc.
General Hospital · 207d
Cleared Jul 17, 2001
CYCLOSPORINE CALIBRATOR
K011112 · DLJ
Dade Behring, Inc.
Chemistry · 97d
Cleared Jul 17, 2001
TORIC LITE LENS
K011256 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 84d
Cleared Jul 17, 2001
MESH URETERAL STENT
K011264 · FAD
Applied Medical Resources Corp.
Gastroenterology & Urology · 83d
Cleared Jul 17, 2001
DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES
K011456 · MRC
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 67d
Cleared Jul 17, 2001
VISUALINE AMPHETAMINE DIPSTRIP ASSAY
K011499 · DKZ
Sun Biomedical Laboratories, Inc.
Toxicology · 63d
Cleared Jul 17, 2001
AMERITEK BRACHYTHERAPY TEMPLATE
K011581 · ITX
Amertek Medical, Inc.
Radiology · 55d
Cleared Jul 17, 2001
UREA NITROGEN (BUN) LIQUID REAGENT
K011596 · CDQ
Jas Diagnostic, Inc.
Chemistry · 54d
Cleared Jul 17, 2001
LATEX EXAMINATION GLOVES- POWDER FREE, BLUE
K011712 · LYY
Pt.Shamrock Manufacturing Corp.
General Hospital · 43d
Cleared Jul 17, 2001
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
K011853 · JJY
Bio-Rad
Immunology · 34d
Cleared Jul 17, 2001
POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K011883 · LYZ
Shijiazhuang Eversharp Plastic...
General Hospital · 29d
Cleared Jul 17, 2001
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K011884 · LYZ
Shijiazhuang Eversharp Plastic...
General Hospital · 29d
Cleared Jul 17, 2001
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
K011982 · FOZ
Bd
General Hospital · 21d
Cleared Jul 16, 2001
AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX,...
K010008 · GZB
Micronet Medical, Inc.
Neurology · 195d
Cleared Jul 16, 2001
LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW
K011076 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 98d