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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
134353–134376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 1988
SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS.
K881899 · DHB
Diagnostic Products Corp.
Immunology · 96d
Cleared Aug 10, 1988
HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5
K882644 · FNM
Huntleigh Technology, Inc.
General Hospital · 44d
Cleared Aug 10, 1988
CENTRIX NEEDLETUBE
K882651 · EKJ
Centrix, Inc.
Dental · 44d
Cleared Aug 10, 1988
EFFNER ILLUMINATED NASAL TRACHEOSTOMA SPECULUM
K882744 · EOB
Effner, Inc.
Ear, Nose, Throat · 40d
Cleared Aug 10, 1988
C-MASK
K882882 · FXX
Promedica Products, Inc.
General Hospital · 30d
Cleared Aug 10, 1988
C-MASK(FLAT)
K882883 · FXX
Promedica Products, Inc.
General Hospital · 30d
Cleared Aug 10, 1988
MX350 (SERIES) CONTROL SYRINGE
K883094 · FMF
Medex, Inc.
General Hospital · 19d
Cleared Aug 10, 1988
CASF STERILIZATION TRAY
K883125 · FSM
Terray Manufacturing, Inc.
General & Plastic Surgery · 15d
Cleared Aug 10, 1988
CASF STERILIZATION TRAY
K883193 · FSM
Terray Manufacturing, Inc.
General & Plastic Surgery · 13d
Cleared Aug 09, 1988
NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS
K875127 · DQO
Novoste Corp.
Cardiovascular · 238d
Cleared Aug 09, 1988
LAITINEN'S TRIGEMINUS STEREOGUIDE
K881132 · HAW
Sandstrom Trade & Technology, Inc.
Neurology · 146d
Cleared Aug 09, 1988
IMPLANTOFIX II IMPLANTABLE DRUG DELIVERY SYSTEM
K881342 · LJT
Burron Medical, Inc.
General Hospital · 132d
Cleared Aug 09, 1988
FIBRINOGENTEST-O
K881685 · GIS
Diatech, Inc.
Hematology · 112d
Cleared Aug 09, 1988
SCOPIX VIDEO IMAGER
K882096 · LMC
Agfa-Gevaert, Inc.
Radiology · 83d
Cleared Aug 09, 1988
FOLEY-TEMP(TM)
K882130 · EYB
Mallinckroot, Inc.
Gastroenterology & Urology · 81d
Cleared Aug 09, 1988
BATTLE CREEK PILLOW
K882264 · IQK
Battle Creek Equipment Co.
Physical Medicine · 70d
Cleared Aug 09, 1988
ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT
K882334 · CFR
Abbott Laboratories
Chemistry · 64d
Cleared Aug 09, 1988
DERMAPIK
K882360 · SCL
Creative Scientific Equipment Corp.
General Hospital · 63d
Cleared Aug 09, 1988
HEARING AID, UNITRON MODEL UI5
K882375 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 62d
Cleared Aug 09, 1988
MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE
K882448 · LJS
Bd Becton Dickinson Vacutainer...
General Hospital · 56d
Cleared Aug 09, 1988
X-RAY MARKER
K882519 · JAC
Karlin Technology, Inc.
Radiology · 53d
Cleared Aug 09, 1988
MONOJECT(R) SNAP-OVER SAFETY CAP
K882614 · JKA
Sherwood Medical Co.
Chemistry · 46d
Cleared Aug 09, 1988
INTERTECH LARGE VOLUME WATER TRAP (LVW)
K882739 · BYH
Intertech Resources, Inc.
Anesthesiology · 39d
Cleared Aug 09, 1988
SAFETY, BLOOD COLLECTION TUBE HOLDER
K882880 · FMI
Ryan Medical, Inc.
General Hospital · 29d