FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
80185–80208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2000
EBT ULTRAFAST CT SCANNER SYSTEM
K001550 · LLZ
Imatron, Inc.
Radiology · 207d
Cleared Dec 11, 2000
TRIDENT ALL POLY CUP
K001956 · JDI
Howmedica Osteonics Corp.
Orthopedic · 167d
Cleared Dec 11, 2000
MODEL 30 CLASSIC PNEUMATONOMETER
K002395 · HKX
Xomed, Inc.
Ophthalmic · 126d
Cleared Dec 11, 2000
ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
K002616 · INI
Electric Mobility Corp.
Physical Medicine · 111d
Cleared Dec 11, 2000
TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353
K002960 · LPH
Zimmer, Inc.
Orthopedic · 80d
Cleared Dec 11, 2000
SYNERGY HA COATED POROUS FEMORAL STEMS
K002996 · MEH
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Dec 11, 2000
MERIT DRAINAGE DEPOT
K003078 · EXF
Merit Medical Systems, Inc.
Gastroenterology & Urology · 69d
Cleared Dec 11, 2000
MILLENNIUM BLADES, MODEL MB101
K003143 · HNO
Millennium Biomedical, Inc.
Ophthalmic · 62d
Cleared Dec 11, 2000
EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP
K994146 · LWJ
Plus Orthopedics
Orthopedic · 369d
Cleared Dec 10, 2000
SNARE,FLEXIBLE
K002927 · FDI
Odon Lifetechnology
Gastroenterology & Urology · 81d
Cleared Dec 08, 2000
LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE
K000594 · JEY
Stryker Leibinger
Dental · 290d
Cleared Dec 08, 2000
HANGER CRANIAL BAND
K001669 · MVA
Hanger Orthopedic Group, Inc.
Neurology · 191d
Cleared Dec 08, 2000
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K001895 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 170d
Cleared Dec 08, 2000
NOVOFINE 31 DISPOSABLE NEEDLE
K002403 · FMI
Novo Norodisk Pharmaceuticals, Inc.
General Hospital · 123d
Cleared Dec 08, 2000
ADVENT IMPLANT SYSTEM
K002614 · DZE
Core-Vent Corp.
Dental · 108d
Cleared Dec 08, 2000
COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE
K002691 · KKX
Com-Med International, Inc.
General Hospital · 101d
Cleared Dec 08, 2000
COOL-TEC ELECTRODES
K002841 · GEI
Seedling Enterprises., LLC
General & Plastic Surgery · 87d
Cleared Dec 08, 2000
PAFLUFOCON C AND E DAILY CONTACT LENS
K002845 · HQD
Paragon Vision Sciences
Ophthalmic · 87d
Cleared Dec 08, 2000
BARD ALL-SILICONE 3-WAY FOLEY CATHETER
K002868 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 86d
Cleared Dec 08, 2000
MAGELLAN VENTILATOR
K002951 · CBK
Oceanic Medical Products, Inc.
Anesthesiology · 78d
Cleared Dec 08, 2000
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8
K002969 · GWF
Xltek
Neurology · 77d
Cleared Dec 08, 2000
STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123
K003002 · JOJ
Steritec Products, Inc.
General Hospital · 73d
Cleared Dec 08, 2000
TISSUELINK BIPOLAR FORCEPS
K003005 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 73d
Cleared Dec 08, 2000
VASCULAR CLOSURE DEVICE
K003169 · GDW
Std Mfg., Inc.
General & Plastic Surgery · 59d