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
87649–87672 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 1998
NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL...
K984245 · HAW
Radionics, Inc.
Neurology · 21d
Cleared Dec 18, 1998
OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS
K984302 · MNH
Osteonics Corp.
Orthopedic · 16d
Cleared Dec 18, 1998
ULTRACARE NEUTRALIZING TABLETS
K984383 · LPN
Allergan, Inc.
Ophthalmic · 10d
Cleared Dec 18, 1998
LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213
K984396 · LRM
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203
K984397 · DHN
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201
K984398 · DHN
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204
K984399 · DHN
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202
K984400 · DHN
Bio-Rad
Immunology · 9d
Cleared Dec 17, 1998
SPIFE ALKALINE HEMOGLOBIN
K982426 · JBD
Helena Laboratories
Hematology · 157d
Cleared Dec 17, 1998
NEW ZIMMER SHOULDER SYSTEM
K982981 · KWT
Zimmer, Inc.
Orthopedic · 113d
Cleared Dec 17, 1998
MODIFICATION TO: PREMIER PLATINUM HPSA
K983255 · LYR
Meridian Diagnostics, Inc.
Microbiology · 93d
Cleared Dec 17, 1998
SCI-PHARM DESENSITIZING VARNISH
K983305 · LBH
Scientific Pharmaceuticals, Inc.
Dental · 87d
Cleared Dec 17, 1998
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN
K983310 · JTT
Accumed Intl., Inc.
Microbiology · 87d
Cleared Dec 17, 1998
SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER
K983403 · CAF
Salter Labs
Anesthesiology · 81d
Cleared Dec 17, 1998
SUPREME II CONTROL SOLUTIONS
K983432 · JJX
Chronimed, Inc.
Chemistry · 79d
Cleared Dec 17, 1998
FASTTAKE ADAPTER, MODEL # P/N 020-072-01
K983468 · JQP
Selfcare, Inc.
Chemistry · 77d
Cleared Dec 17, 1998
FERTILMARQ TEST KIT
K983473 · POV
Embryotech Laboratories, Inc.
Hematology · 76d
Cleared Dec 17, 1998
CARESIDE CALCIUM, ORIGINAL
K983789 · CJY
Careside, Inc.
Chemistry · 51d
Cleared Dec 17, 1998
ALASTAT MICROPLATE MIXED ALLERGEN PANELS
K983954 · DHB
Diagnostic Products Corp.
Immunology · 42d
Cleared Dec 17, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM
K984175 · MID
Zeus Scientific, Inc.
Immunology · 27d
Cleared Dec 17, 1998
OASIS
K984218 · HIS
Glimex Corp.
Obstetrics & Gynecology · 23d
Cleared Dec 17, 1998
VARIANT II HEMOGLOBIN A1C PROGRAM
K984268 · LCP
Bio-Rad
Hematology · 17d
Cleared Dec 17, 1998
HEARTSTREAM ELECTRODE ADAPTER
K984286 · MKJ
Hewlett-Packard Co.
Cardiovascular · 16d
Cleared Dec 17, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME...
K984315 · MOB
Zeus Scientific, Inc.
Immunology · 14d