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
93049–93072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 18, 1997
MORPHEE PLUS ALPHA
K964019 · BZD
Nellcor Puritan Bennett, Inc.
Anesthesiology · 254d
Cleared Jun 18, 1997
SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT
K964373 · DWF
3M Healthcare
Cardiovascular · 229d
Cleared Jun 18, 1997
SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT
K964374 · DWF
3M Healthcare
Cardiovascular · 229d
Cleared Jun 18, 1997
LEGIONELLA ELISA TEST SYSTEM
K970149 · LHL
Zeus Scientific, Inc.
Microbiology · 154d
Cleared Jun 18, 1997
BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL
K970809 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 105d
Cleared Jun 18, 1997
PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS
K971010 · LIT
Cordis Corp.
Cardiovascular · 90d
Cleared Jun 18, 1997
LSF TRIAD TOTAL HIP SYSTEM
K971020 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Jun 18, 1997
UNIVERSAL DRIVE SYSTEM
K971059 · HRX
Linvatec Corp.
Orthopedic · 86d
Cleared Jun 18, 1997
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K971289 · KWP
Osteotech, Inc.
Orthopedic · 72d