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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
124873–124896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 1990
AFFINITY HCG TEST SYSTEM
K902720 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 50d
Cleared Aug 09, 1990
LSF CEMENTED FEMORAL HIP
K902727 · JDI
Implant Technology, Inc.
Orthopedic · 49d
Cleared Aug 09, 1990
SEROZYME FREE T3 IMMUNOASSAY
K902748 · KHQ
Advanced Magnetics, Inc.
Toxicology · 48d
Cleared Aug 09, 1990
LAMINECTOMY ROGEUR
K902819 · LXH
Ruggles Corp.
Orthopedic · 43d
Cleared Aug 09, 1990
ARGENCO 10 TYPE I DENTAL GOLD ALLOY
K902899 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Aug 09, 1990
ARGENCO M-1 TYPE II DENTAL GOLD ALLOY
K902900 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Aug 09, 1990
ARGENCO 16 TYPE I DENTAL GOLD ALLOY
K902901 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Aug 09, 1990
ARGENCO 17 TYPE II DENTAL GOLD ALLOY
K902903 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Aug 09, 1990
ARGENCO 20 (20 CT) TYPE II DENTAL GOLD ALLOY
K902904 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Aug 09, 1990
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)
K902925 · LFX
Vitek Systems, Inc.
Microbiology · 37d
Cleared Aug 09, 1990
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3
K902938 · LLL
General Biometrics, Inc.
Immunology · 37d
Cleared Aug 09, 1990
FIXATION STAPLE
K903022 · JDR
Onyx Medical Corp.
Orthopedic · 30d
Cleared Aug 09, 1990
ROCHE ISOMUNE- CK
K903025 · JHS
Roche Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Aug 09, 1990
IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4
K903047 · LLL
General Biometrics, Inc.
Immunology · 29d
Cleared Aug 09, 1990
ARGENCO 18
K903059 · EJT
Argen Precious Metals, Inc.
Dental · 31d
Cleared Aug 09, 1990
SEROCARD HSV IGG ANTIBODY TEST KIT
K903070 · LGC
Disease Detection International, Inc.
Microbiology · 28d
Cleared Aug 09, 1990
INNOFLUOR (TM) AMIKACIN REAGENT SET
K903100 · KLQ
Innotron of Oregon, Inc.
Toxicology · 27d
Cleared Aug 09, 1990
SYNERMED CHLORIDE REAGENT KIT
K903103 · CHG
Synermed, Inc.
Chemistry · 27d
Cleared Aug 09, 1990
ARGENCO 1
K903119 · EJT
Argen Precious Metals, Inc.
Dental · 24d
Cleared Aug 09, 1990
ARGENCO 23
K903120 · EJT
Argen Precious Metals, Inc.
Dental · 24d
Cleared Aug 09, 1990
CHEM-CHEX-ALT
K903147 · JJX
Streck Laboratories, Inc.
Chemistry · 22d
Cleared Aug 09, 1990
EMIT ETHYL ALCOHOL ASSAY
K903153 · DIC
Syva Co.
Toxicology · 22d
Cleared Aug 09, 1990
EURAMARK 610 PHOTOMETER
K903164 · JJQ
Euro-American Marketing Group, Inc.
Chemistry · 22d
Cleared Aug 09, 1990
BROAD SELF-COMPRESSING PLATE
K903252 · HRS
Onyx Medical Corp.
Orthopedic · 16d