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
76297–76320 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2002
SAFE
K013773 · HIS
Ssn Medical Products Sdn. Bhd.
Obstetrics & Gynecology · 72d
Cleared Jan 24, 2002
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE...
K013899 · CDD
Ortho-Clinical Diagnostics
Toxicology · 62d
Cleared Jan 24, 2002
MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
K013964 · KXK
Cp Medical
Radiology · 52d
Cleared Jan 24, 2002
HEMOCHRON JR. CITRATE APTT CUVETTE
K014008 · GFO
Itc, Inc.
Hematology · 50d
Cleared Jan 24, 2002
CAPTIAM SYPHILIS-G ASSAY
K014233 · LIP
Trinity Biotech, Plc
Microbiology · 29d
Cleared Jan 24, 2002
DELSONIC 2000
K014238 · ELC
Deldent , Ltd.
Dental · 29d
Cleared Jan 23, 2002
KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E
K010923 · MHX
Siemens Elema AB
Cardiovascular · 302d
Cleared Jan 23, 2002
VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)
K011625 · DXN
Vasocor, Inc.
Cardiovascular · 243d
Cleared Jan 23, 2002
EXEL COMFORTPOINT INSULIN PEN NEEDLE
K011757 · FMI
Exelint Intl. Co.
General Hospital · 231d
Cleared Jan 23, 2002
BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE
K011967 · FOZ
Bd
General Hospital · 212d
Cleared Jan 23, 2002
INTRAORAL LENS OPTION TO SPECTROSHADE
K012744 · EIA
Mht Optic Research AG
Dental · 160d
Cleared Jan 23, 2002
PORTABLE INTENSIVE CARE UNIT
K012766 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 159d
Cleared Jan 23, 2002
CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO...
K013303 · LZA
Latexx Manufacturing Sdn.Bhd.
General Hospital · 111d
Cleared Jan 23, 2002
SCI-PHARM POST SECURE
K013555 · EMA
Scientific Pharmaceuticals, Inc.
Dental · 90d
Cleared Jan 23, 2002
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW
K013558 · KWQ
Blackstone Medical, Inc.
Orthopedic · 90d
Cleared Jan 23, 2002
PRECISION PLUS TUNA OFFICE SYSTEM
K014224 · GEI
Vidamed, Inc.
General & Plastic Surgery · 28d
Cleared Jan 23, 2002
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING...
K020019 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 20d
Cleared Jan 22, 2002
DIOMED 15 DIODE LASER
K012398 · GEX
Diomed, Ltd.
General & Plastic Surgery · 179d
Cleared Jan 22, 2002
VANGUARD REPROCESSED INFLATION DEVICES
K012480 · MAV
Vanguard Medical Concepts, Inc.
Cardiovascular · 173d
Cleared Jan 22, 2002
CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP...
K012602 · FXX
Crosstex Intl.
General Hospital · 162d
Cleared Jan 22, 2002
UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES
K013163 · LYY
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 123d
Cleared Jan 22, 2002
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
K013262 · LYY
Great Glove (Thailand) Co. , Ltd.
General Hospital · 113d
Cleared Jan 22, 2002
ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
K013465 · LCP
Diabetes Technologies, Inc.
Hematology · 96d
Cleared Jan 22, 2002
PUMP TUBING
K013578 · DWE
Terumo Cardiovascular Systems Corp.
Cardiovascular · 85d