FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
78673–78696 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 16, 2001
VIADUCT MICROENDOSCOPE AND ACCESSORIES
K011189 · GCJ
Acueity, Inc.
General & Plastic Surgery · 89d
Cleared Jul 16, 2001
BIOPSY SITE MARKER
K011402 · FZP
Senorx, Inc.
General & Plastic Surgery · 70d
Cleared Jul 16, 2001
CAVEX COLORCHANGE
K011419 · ELW
Cavex Holland BV
Dental · 68d
Cleared Jul 16, 2001
SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT...
K011525 · JLW
Biosafe Laboratories, Inc.
Chemistry · 60d
Cleared Jul 16, 2001
CONCORD 72
K011626 · EJT
Gateway Alloys, Inc.
Dental · 48d
Cleared Jul 16, 2001
CONCORD 82
K011628 · EJT
Gateway Alloys, Inc.
Dental · 48d
Cleared Jul 16, 2001
SYNTHETIC POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K011885 · LYZ
Shijiazhuang Eversharp Plastic...
General Hospital · 28d
Cleared Jul 16, 2001
MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100
K011955 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 24d