FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
123649–123672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 02, 1991
STIMTRAC PC, CATALOG NO. 78-8510
K903128 · GZJ
Stimtech Products
Neurology · 170d
Cleared Jan 02, 1991
ORAL-CATH SUCTION CATHETER
K903552 · BSY
Concord Protex
Anesthesiology · 149d
Cleared Jan 02, 1991
MODEL OSP, SANDHILL AMS
K904231 · FAD
Sandhill Scientific, Inc.
Gastroenterology & Urology · 127d
Cleared Jan 02, 1991
CUSTOMED CARDIOVASCULAR PACK
K904693 · KKX
Customed, Inc.
General Hospital · 78d
Cleared Jan 02, 1991
CUSTOMED ANGIODRAPE PACK FEMORAL
K904694 · KKX
Customed, Inc.
General Hospital · 78d
Cleared Jan 02, 1991
GDC-1501
K904695 · EJT
Deringer-Ney, Inc.
Dental · 78d
Cleared Jan 02, 1991
OXYGEN/AIR TUBING
K904715 · CAF
Tri/Bor Medical, Inc.
Anesthesiology · 76d
Cleared Jan 02, 1991
AERO-GEN NEBULIZER
K904716 · CAF
Tri/Bor Medical, Inc.
Anesthesiology · 76d
Cleared Jan 02, 1991
DISPOSABLE FACE MASK
K904719 · BYG
Tri/Bor Medical, Inc.
Anesthesiology · 76d
Cleared Jan 02, 1991
VISTAR
K905070 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 54d
Cleared Jan 02, 1991
TPN FLUID TRANSFER SET
K905201 · LHI
Mcgaw, Inc.
General Hospital · 43d
Cleared Jan 02, 1991
LANEX EXAM GLOVES
K905667 · LYY
Mokiem & Julian Industrial Corp.
General Hospital · 15d
Cleared Jan 01, 1991
PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC
K896851 · JDI
Lima Intl. Corp.
Orthopedic · 392d
Cleared Dec 31, 1990
ORION STERILE OR TOWELS
K903117 · KKX
Orion Life Systems, Inc.
General Hospital · 168d
Cleared Dec 31, 1990
COOL CAST(R)
K903946 · LGF
Hawthorne Products, Inc.
Orthopedic · 126d
Cleared Dec 31, 1990
VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODES
K904560 · GEI
Valleylab, Inc.
General & Plastic Surgery · 87d
Cleared Dec 31, 1990
FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM
K904795 · GKH
Bd Becton Dickinson Vacutainer...
Hematology · 73d
Cleared Dec 31, 1990
PRIDE SPIRIT
K905271 · INI
Pride Health Care, Inc.
Physical Medicine · 40d
Cleared Dec 31, 1990
ROMFLEX REHABILITATION EQUIPMENT
K905299 · BXB
Dyna Flex, Intl.
Physical Medicine · 33d
Cleared Dec 31, 1990
LINGRAPHICA VISUAL LANGUAGE PROSTHESIS
K905576 · ILQ
Tolfa Corp.
Physical Medicine · 19d
Cleared Dec 31, 1990
NONABSORBABLE POLYPROPYLENE SURGICAL MESH
K905655 · FTL
United States Surgical, A Division of...
General & Plastic Surgery · 13d
Cleared Dec 31, 1990
BRODA WHEELCHAIR
K905671 · IOR
Broda Ent., Inc.
Physical Medicine · 13d
Cleared Dec 28, 1990
RESP-EZ(TM) RESPIRATORY MONITORING BELT
K903300 · BZQ
Epm Information Systems, Inc.
Anesthesiology · 157d
Cleared Dec 28, 1990
OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING
K903844 · JXG
Cordis Corp.
Neurology · 129d