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
93553–93576 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 1997
H.V. PULSE LAVAGE (L31 SERIES)
K970916 · FQH
Global Medical Products, Inc.
General Hospital · 100d
Cleared Jun 20, 1997
FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT
K971047 · KWD
Nexa Orthopedics, Inc.
Orthopedic · 91d
Cleared Jun 20, 1997
DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION
K971055 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Jun 20, 1997
CHOLESTEROL REAGENT
K971072 · CHH
Derma Media Lab., Inc.
Chemistry · 88d
Cleared Jun 20, 1997
BLINK EXTERNAL EYELID WEIGHT
K971245 · MML
Ipax, Inc.
Ophthalmic · 78d
Cleared Jun 20, 1997
LEO 7000 QUADRATURE KNEE COIL
K971246 · MOS
Usa Instruments, Inc.
Radiology · 78d
Cleared Jun 20, 1997
STRATASYS FDM MEDMODELER SYSTEM
K971290 · LLZ
Paladin Medical, Inc.
Radiology · 74d
Cleared Jun 20, 1997
TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A,...
K971296 · ESD
National Hearing Aid Dist., Inc.
Ear, Nose, Throat · 74d
Cleared Jun 20, 1997
TRIGLYCERIDES, TG, OR TRIG
K971324 · CDT
Carolina Liquid Chemistries Corp.
Chemistry · 71d
Cleared Jun 20, 1997
QUANTA LITE RF IGM
K971614 · DHR
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Jun 20, 1997
RESISTICK SOLID LAPAROSCOPIC ELECTRODES
K971621 · KNF
Aaron Medical Industries
Obstetrics & Gynecology · 50d
Cleared Jun 20, 1997
MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM
K971622 · KIF
Mpl Technologies, Inc.
Dental · 49d
Cleared Jun 20, 1997
NDC DENTAL SYSTEM, VERSION 1.5 X-RAY AND VIDEO
K971714 · LLZ
National Data Corp.
Radiology · 42d
Cleared Jun 20, 1997
NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION
K971774 · EFB
Nsk Nakanishi, Inc.
Dental · 38d
Cleared Jun 20, 1997
COAXIAL NEEDLE
K971842 · FCG
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 32d
Cleared Jun 20, 1997
VIRGO AMA ELISA KIT
K971909 · DBM
Hemagen Diagnostics, Inc.
Immunology · 28d
Cleared Jun 20, 1997
PLANMECA INTRACAM
K972033 · EIA
Planmeca Oy
Dental · 18d
Cleared Jun 19, 1997
INDICARD TEST
K964015 · MJM
Litmus Concepts, Inc.
Microbiology · 255d
Cleared Jun 19, 1997
IMPLEX A-240 HEP ACETABULAR CUP SYSTEM
K964509 · LPH
Implex Corp.
Orthopedic · 223d
Cleared Jun 19, 1997
TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS
K964650 · LPH
Depuy, Inc.
Orthopedic · 211d
Cleared Jun 19, 1997
INFECTION CONTROL CARTRIDGE
K964942 · EIA
Dentalpure Corp.
Dental · 191d
Cleared Jun 19, 1997
MICROJECT MODEL PCA-1
K965222 · MEB
Microject, Inc.
General Hospital · 170d
Cleared Jun 19, 1997
PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS
K971547 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 52d
Cleared Jun 19, 1997
SURGITRON MODEL FFPF-EMC
K972072 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 16d