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
87145–87168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 17, 1998
ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05
K984325 · JJY
Bio-Rad
Immunology · 14d
Cleared Dec 17, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST...
K984347 · MID
Zeus Scientific, Inc.
Immunology · 13d
Cleared Dec 16, 1998
BRAUN PREFILLED SYRINGE
K970736 · FOZ
B.Braun Medical, Inc.
General Hospital · 656d
Cleared Dec 16, 1998
UNIPULSE CO2 SURGICAL LASER SYSTEM
K980475 · GEX
Nidek, Inc.
General & Plastic Surgery · 313d
Cleared Dec 16, 1998
IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT
K980637 · JWH
Implex Corp.
Orthopedic · 300d
Cleared Dec 16, 1998
DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION
K980925 · JWH
Howmedica Corp.
Orthopedic · 280d
Cleared Dec 16, 1998
DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION
K980926 · JDI
Howmedica Corp.
Orthopedic · 280d
Cleared Dec 16, 1998
LASEAWAY ALEXANDRITE LASER SYSTEM
K982316 · GEX
Silver Creek, Inc.
General & Plastic Surgery · 167d
Cleared Dec 16, 1998
AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)
K982650 · CAC
Dideco S.P.A.
Anesthesiology · 139d