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
86281–86304 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 1999
BQ/BM INTEGRATED LASER DELIVERY SYSTEM
K990665 · HQF
American Laser Corp.
Ophthalmic · 76d
Cleared May 17, 1999
MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)
K990669 · LTZ
Dongkuk Techco Rubber Industries Sdn....
Obstetrics & Gynecology · 76d
Cleared May 17, 1999
ORTHO-GLOW GLITTER
K990699 · EBI
Harry J. Bosworth Co.
Dental · 75d
Cleared May 17, 1999
GALLINI BYCUT NEEDLE
K990716 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 74d
Cleared May 17, 1999
NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE
K990840 · LZA
Terang Nusa Sdn Bhd
General Hospital · 63d
Cleared May 17, 1999
NUGARD NITRIL NITRILE EXAMINATION GLOVE
K990841 · LZA
Terang Nusa Sdn Bhd
General Hospital · 63d
Cleared May 17, 1999
TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION...
K990848 · LXT
Immedica, Inc.
Orthopedic · 63d
Cleared May 17, 1999
PRE POWDERED LATEX EXAMINATION GLOVES
K990879 · LYY
Apl Products Sdn. Bhd.
General Hospital · 62d
Cleared May 17, 1999
JACKSON ESOPHAGEAL DILATOR
K990935 · KNQ
Pilling Weck Surgical
Gastroenterology & Urology · 59d
Cleared May 17, 1999
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
K991030 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 49d
Cleared May 17, 1999
IONOSIT BOND
K991172 · EMA
Dmg Chemisch Pharmazeutische Fabrik GmbH
Dental · 40d
Cleared May 17, 1999
OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERT
K991461 · JWH
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared May 17, 1999
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
K991627 · LBI
Respironics, Inc.
General Hospital · 6d
Cleared May 14, 1999
THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO...
K983715 · LTK
Bayer Corp.
Immunology · 205d
Cleared May 14, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS...
K983875 · LTK
Ortho-Clinical Diagnostics, Inc.
Immunology · 193d
Cleared May 14, 1999
KERATOME SYSTEM, MODEL K3000
K984537 · HMY
Insight Technologies Instruments, LLC
Ophthalmic · 144d
Cleared May 14, 1999
OPTICAL FORCEPS
K990561 · JEK
Pilling Weck Surgical
Ear, Nose, Throat · 81d
Cleared May 14, 1999
TAS ANALYZER, MODEL 1009
K990566 · JPA
Cardiovascular Diagnostics, Inc.
Hematology · 81d
Cleared May 14, 1999
SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO...
K990568 · GEX
Synergetics, Inc.
General & Plastic Surgery · 80d
Cleared May 14, 1999
EXCELART
K990620 · LNH
Toshiba America Mri, Inc.
Radiology · 78d
Cleared May 14, 1999
CONSEAL F
K990650 · EBC
Southern Dental Industries, Inc.
Dental · 74d
Cleared May 14, 1999
FLEXNEEDLE PLUS
K990693 · FPA
Act Medical, Inc.
General Hospital · 72d
Cleared May 14, 1999
ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210,...
K991048 · DHB
Pharmacia & Upjohn Co.
Immunology · 45d
Cleared May 14, 1999
K-ASSAY CRP
K991224 · DCK
Kamiya Biomedical Co.
Immunology · 32d