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
84145–84168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1999
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINO GLOVES, WITH...
K993097 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 41d
Cleared Oct 27, 1999
ILLUSION
K993192 · EBF
Bisco, Inc.
Dental · 64d
Cleared Oct 27, 1999
SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE...
K993231 · LYZ
Shinemound Enterprise, Inc.
General Hospital · 30d
Cleared Oct 27, 1999
SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH...
K993240 · LYZ
Shinemound Enterprise, Inc.
General Hospital · 30d
Cleared Oct 27, 1999
SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES
K993258 · LZA
Supermax Sdn Bhd
General Hospital · 28d
Cleared Oct 27, 1999
IQ NASAL MASK, MODEL P/N 50160
K993269 · BZD
Sleepnet Corporation
Anesthesiology · 27d
Cleared Oct 27, 1999
ARIA LX CPAP SYSTEM
K993307 · BZD
Respironics, Inc.
Anesthesiology · 23d
Cleared Oct 27, 1999
ROTORBLADE SUTURE ANCHOR
K993373 · MAI
Li Medical Technologies, Inc.
Orthopedic · 20d
Cleared Oct 27, 1999
VIRTUOSO LX SMART CPAP SYSTEM
K993433 · BZD
Respironics, Inc.
Anesthesiology · 15d
Cleared Oct 26, 1999
SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES
K982521 · DRX
Leonhard Lang Co.
Cardiovascular · 463d
Cleared Oct 26, 1999
ENDOREZ
K992097 · KIF
Ultradent Products, Inc.
Dental · 127d
Cleared Oct 26, 1999
SPECTRUM DESIGNS SPECTRAGEL
K992522 · MDA
Spectrum Designs, Inc.
General & Plastic Surgery · 90d
Cleared Oct 26, 1999
TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM
K992544 · HEX
Circon Corp.
Obstetrics & Gynecology · 88d
Cleared Oct 26, 1999
GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)
K992926 · HHK
Ri Mos. S.R.L.
Obstetrics & Gynecology · 56d
Cleared Oct 26, 1999
GOLD CORE 55
K993173 · EJT
Jeneric/Pentron, Inc.
Dental · 34d
Cleared Oct 26, 1999
GOLD CORE 75
K993175 · EJT
Jeneric/Pentron, Inc.
Dental · 34d
Cleared Oct 25, 1999
HYBRID CAPTURE II CT-ID TEST
K990023 · LSK
Digene Corp.
Microbiology · 293d
Cleared Oct 25, 1999
FLEXIBLE FIBERSCOPES & ACCESSORIES
K990397 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 258d
Cleared Oct 25, 1999
ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND...
K991140 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 203d
Cleared Oct 25, 1999
DADE BEHRING N HIGH SENSITIVITY CRP ASSAY
K991385 · DCK
Dade Behring, Inc.
Immunology · 187d
Cleared Oct 25, 1999
MICROWAVE DELIVERY SYSTEM, MODEL MMC-300
K991456 · MWY
Microwave Medical, Inc.
General & Plastic Surgery · 182d
Cleared Oct 25, 1999
INTRAOP CATHETER
K991543 · MEB
I-Flow Corp.
General Hospital · 175d
Cleared Oct 25, 1999
STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
K991696 · DZI
Stryker Instruments
Dental · 160d
Cleared Oct 25, 1999
INTERACOUSTICS EP 15 ABR STAND ALONE UNIT
K991853 · GWJ
Idem (Int'L Dist. of Electronics For...
Neurology · 146d