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
86569–86592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1999
SELF CATH SET/SAFETY CATH
K983010 · FCM
Rusch Intl.
Gastroenterology & Urology · 168d
Cleared Feb 12, 1999
GAUZE, SPONGES, CAT # 11-003
K983016 · EFQ
Vitalcare Group, Inc.
General & Plastic Surgery · 168d
Cleared Feb 12, 1999
NORIAN PERIODONTAL/DENTAL CEMENT (PDC)
K983104 · LYC
Norian Corp.
Dental · 161d
Cleared Feb 12, 1999
TRAJECTORY GUIDE, MODEL # TGX-XXX
K983539 · HAW
Image-Guided Neurologics, Inc.
Neurology · 126d
Cleared Feb 12, 1999
UP-GRADE AND UP-GRADE PRO
K983887 · FLL
Medisim, Ltd.
General Hospital · 102d
Cleared Feb 12, 1999
MAMMARY SIZER, MAMMARY PROTHESIS SIZER
K984106 · MRD
Specialty Surgical Products, Inc.
General & Plastic Surgery · 87d
Cleared Feb 12, 1999
AESCULAP AXIAL CLIP APPLIER
K984109 · HCI
Aesculap, Inc.
Neurology · 87d
Cleared Feb 12, 1999
SCAREASE & SCAREASE ADHESIVE GEL
K984115 · MDA
Scarease, Inc.
General & Plastic Surgery · 87d
Cleared Feb 12, 1999
NATURA DENTURE TEETH
K984134 · ELM
Davis Schottlander & Davis, Ltd.
Dental · 86d
Cleared Feb 12, 1999
FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR
K984221 · LNH
Siemens Corp.
Radiology · 79d
Cleared Feb 12, 1999
NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDERED
K984309 · LZA
Sumirubber Industries (Kedah) Sdn. Bhd.
General Hospital · 72d
Cleared Feb 12, 1999
130 MODIFIED INTEGRAL FEMORAL COMPONENT
K984408 · LPH
Biomet, Inc.
Orthopedic · 65d
Cleared Feb 12, 1999
ELK LASER FILM DIGITIZER
K984409 · LMA
Nishimoto Sangyo Co., Ltd.
Radiology · 65d
Cleared Feb 12, 1999
AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147
K984442 · JEC
Hand Biomechanics Lab, Inc.
Orthopedic · 60d
Cleared Feb 12, 1999
SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM
K990005 · KWQ
Spinal Concepts, Inc.
Orthopedic · 39d
Cleared Feb 12, 1999
D-SIGN III (R&D PROJECT DW264#7)
K990077 · EJS
Ivoclar North America, Inc.
Dental · 32d
Cleared Feb 12, 1999
D-SIGN IV (R&D PROJECT DW265#37)
K990078 · EJS
Ivoclar North America, Inc.
Dental · 32d
Cleared Feb 12, 1999
CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED...
K990083 · FPA
Sims Deltec, Inc.
General Hospital · 32d
Cleared Feb 12, 1999
WILSON-COOK PANCREATIC WEDGE STENT
K990130 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 29d
Cleared Feb 12, 1999
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM
K990259 · FRN
Disetronic Medical Systems
General Hospital · 16d
Cleared Feb 11, 1999
DS30 HCY HOMOCYSTEINE ASSAY KIT
K982003 · LPS
Drew Scientific , Ltd.
Hematology · 248d
Cleared Feb 11, 1999
UNI-GOLD STREP A TEST KIT
K982373 · GTY
Trinity Biotech, Plc
Microbiology · 219d
Cleared Feb 11, 1999
MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES
K983702 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 113d
Cleared Feb 11, 1999
RIGID GAS PERMEABLE CONTACT LENS SOLUTION
K983836 · MRC
Polymer Technology Div. Wilmington...
Ophthalmic · 104d