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
88225–88248 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1998
EPIFILM OTOLOGIC LAMINA
K982870 · KHJ
Xomed, Inc.
Ear, Nose, Throat · 81d
Cleared Nov 03, 1998
EARSCAN 3
K982878 · EWO
Micro Audiometrics Corp.
Ear, Nose, Throat · 81d
Cleared Nov 03, 1998
MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA
K982921 · MOS
Medrad, Inc.
Radiology · 76d
Cleared Nov 03, 1998
MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC
K982959 · LNH
Medrad, Inc.
Radiology · 71d
Cleared Nov 03, 1998
BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24
K983101 · MJC
C.R. Bard, Inc.
Gastroenterology & Urology · 61d
Cleared Nov 03, 1998
COAMATIC HEPARIN
K983178 · KFF
Instrumentation Laboratory CO
Hematology · 53d
Cleared Nov 03, 1998
SMALL VAGINAL/RECTAL ELECTRODE
K983206 · KPI
Empi
Gastroenterology & Urology · 50d
Cleared Nov 03, 1998
SUPER PORCELAIN ADDMATE
K983247 · EIH
Noritake Co., Inc.
Dental · 48d
Cleared Nov 03, 1998
ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152,...
K983294 · KPE
Baxter Healthcare Corp
General Hospital · 43d
Cleared Nov 03, 1998
MODIFICATION TO TIELLE HYDROPOLMER DRESSING
K983394 · MGP
Johnson & Johnson Medical, Div. of...
General & Plastic Surgery · 39d
Cleared Nov 03, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
K983513 · JJY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
Cleared Nov 03, 1998
MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700
K983562 · GKZ
Cdc Technologies, Inc.
Hematology · 21d
Cleared Nov 03, 1998
NEEDLE GUIDE
K983621 · IZH
Remington Medical, Inc.
Radiology · 19d
Cleared Nov 02, 1998
VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
K980576 · JAQ
Varian Medical Systems, Inc.
Radiology · 258d
Cleared Nov 02, 1998
LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED
K981600 · LYY
Young Innovations, LLC Dba Plak Smacker
General Hospital · 182d
Cleared Nov 02, 1998
UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE)
K982611 · LYY
Uniject Gloves Pcl
General Hospital · 129d
Cleared Nov 02, 1998
RT DESKTOP
K982713 · IYE
Elekta Oncology Systems, Ltd.
Radiology · 90d
Cleared Nov 02, 1998
SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200
K982717 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Nov 02, 1998
9303 NEONATAL/ADULT VITAL SIGNS MONITOR
K982776 · DQA
Cas Medical Systems, Inc.
Anesthesiology · 88d
Cleared Nov 02, 1998
CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM
K982836 · FRN
Sims Deltec, Inc.
General Hospital · 82d
Cleared Nov 02, 1998
CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
K982839 · MEA
Sims Deltec, Inc.
General Hospital · 82d
Cleared Nov 02, 1998
MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC
K982919 · MOS
Medrad, Inc.
Radiology · 75d
Cleared Nov 02, 1998
MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC
K982932 · LNH
Medrad, Inc.
Radiology · 74d
Cleared Nov 02, 1998
CITREX HOSPITAL SPRAY DISINFECTANT
K982985 · LRJ
Caltech Industries, Inc.
General Hospital · 68d