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
116089–116112 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 1992
TECHNICON H*2
K923237 · GKZ
Heraeus Kulzer, Inc.
Hematology · 71d
Cleared Sep 11, 1992
KODAK EKTASCAN IMAGELINK QUALITY CONTROL WORKSTATI
K923270 · LLZ
Eastman Kodak Company
Radiology · 67d
Cleared Sep 11, 1992
TRACE ALBUMIN-MR REAGENT
K923322 · CIX
Trace Scientific , Ltd.
Hematology · 66d
Cleared Sep 11, 1992
PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED
K923445 · LYR
Hycor Biomedical, Inc.
Microbiology · 65d
Cleared Sep 11, 1992
BURN DRESSING
K923846 · NAB
Medical Action Industries, Inc.
General & Plastic Surgery · 42d
Cleared Sep 11, 1992
O.R. CONCEPTS CABLE HARNESS
K924264 · GEI
O.R. Concepts, Inc.
General & Plastic Surgery · 18d
Cleared Sep 10, 1992
ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO.
K914364 · LGZ
North American Technical Services Corp.
General Hospital · 345d
Cleared Sep 10, 1992
MODEL 6213 REMOTE ALARM
K914424 · CBK
Aequitron Medical, Inc.
Anesthesiology · 343d
Cleared Sep 10, 1992
BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET
K920090 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 246d
Cleared Sep 10, 1992
MRX-865
K921130 · ITY
Mrx-Ray Tube Corp.
Radiology · 184d
Cleared Sep 10, 1992
FIRST AID KIT
K921976 · LYY
The Home Emergency Room
General Hospital · 136d
Cleared Sep 10, 1992
AXIOM TOTAL KNEE SYSTEM AND PLUS TOTAL KNEE SYSTEM
K922734 · JWH
Orthomet, Inc.
Orthopedic · 94d
Cleared Sep 10, 1992
MAMMOSCAN
K923061 · IZH
Fischer Imaging Corp.
Radiology · 77d
Cleared Sep 10, 1992
CARDIAC TRIAD NEW DETECTOR OPTION
K923151 · KPS
Trionix Research Laboratory, Inc.
Radiology · 78d
Cleared Sep 10, 1992
BIAD NEW DETECTOR OPTION
K923345 · KPS
Trionix Research Laboratory, Inc.
Radiology · 78d
Cleared Sep 10, 1992
IN-THE-EAR HEARING AID
K923918 · ESD
Benway-Haworth-Lawlor Hearing Aids, Inc.
Ear, Nose, Throat · 36d
Cleared Sep 10, 1992
CYBERNETIC OPTION (CYBER I)
K923986 · ESD
Qualitone
Ear, Nose, Throat · 34d
Cleared Sep 09, 1992
PATIENT EXAMINATION GLOVES (MAYCARE)
K915329 · LYY
Malaysian Healthcare Sdn. Bhd
General Hospital · 288d
Cleared Sep 09, 1992
MYOTRAC2
K915858 · HCC
Thought Technology , Ltd.
Neurology · 257d
Cleared Sep 09, 1992
MYOTRAC/S, MYODAC/S
K915859 · HCC
Thought Technology , Ltd.
Neurology · 257d
Cleared Sep 09, 1992
CORDIS SHUTTLE CATHETER W/ SIDEHOLES
K921311 · DQY
Cordis Corp.
Cardiovascular · 175d
Cleared Sep 09, 1992
COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE
K921407 · EBF
Ultradent Products, Inc.
Dental · 169d
Cleared Sep 09, 1992
ENAMEL AND PORCELAIN ETCH PRODUCT LINE
K921409 · EBF
Ultradent Products, Inc.
Dental · 169d
Cleared Sep 09, 1992
ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE
K921598 · EBF
Ultradent Products, Inc.
Dental · 159d