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
148873–148896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 1985
OMNI PHASE PENILE PROSTHESIS
K850019 · FAE
Dacomed Corp.
Gastroenterology & Urology · 96d
Cleared Apr 09, 1985
XMA 325 (X-RAY GENERATOR)
K850117 · IZO
Summit Industries, Inc.
Radiology · 85d
Cleared Apr 09, 1985
XMA INTEGRATED TABLE
K850118 · IXQ
Summit Industries, Inc.
Radiology · 85d
Cleared Apr 09, 1985
PRN ECG ELECTRODE
K850130 · DRX
Consolidated Medical Equipment, Inc.
Cardiovascular · 85d
Cleared Apr 09, 1985
DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC
K850132 · DRX
Consolidated Medical Equipment, Inc.
Cardiovascular · 85d
Cleared Apr 09, 1985
}IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR
K850167 · KPI
Urologics, Inc.
Gastroenterology & Urology · 83d
Cleared Apr 09, 1985
BOSCH IN THE EAR HEARING AID SUPERSTAR
K850188 · ESD
Robert Bosch Corp.
Ear, Nose, Throat · 81d
Cleared Apr 09, 1985
MASTER KIT A
K850246
Pro-Lab, Inc.
General & Plastic Surgery · 77d
Cleared Apr 09, 1985
VASCULON I.V. CANNULAE
K850278 · FOZ
Viggo Products
General Hospital · 76d
Cleared Apr 09, 1985
VIGGO ARTERIAL CANNULA
K850349 · FOZ
Viggo Products
General Hospital · 71d
Cleared Apr 09, 1985
RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE
K850365 · DSF
Eaton Medical Group
Cardiovascular · 69d
Cleared Apr 09, 1985
MODEL 78231D CARDIAC OUTPUT MODULE
K850568 · DXG
Hewlett-Packard Co.
Cardiovascular · 56d
Cleared Apr 09, 1985
IMED 440 INFUSION PUMP & ADMINISTRATION SET
K850653 · FRN
Imed Corp.
General Hospital · 49d
Cleared Apr 09, 1985
PROMINJECT PROGRAMMABLE INFUSION PUMP
K850669 · FRN
Pharmacia, Inc.
General Hospital · 48d
Cleared Apr 09, 1985
CORMED II AMBULATORY INFUSION PUMP
K850674 · FRN
Cormed, Inc., Sub. C.R.Bard, Inc.
General Hospital · 48d
Cleared Apr 09, 1985
ACUFLO VOLUMETRIC CONTROLLED DELIVERY SYS 2000
K850729 · FRN
Surgidev Corp.
General Hospital · 46d
Cleared Apr 09, 1985
AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR
K850825 · FPB
Pall Biomedical Products Co.
General Hospital · 40d
Cleared Apr 09, 1985
POSIDYNE SOLUTION CONTAINER FILTER, RECORDER #96
K850826 · FPB
Pall Biomedical Products Co.
General Hospital · 40d
Cleared Apr 09, 1985
EQUIPMENT SNAP KOVERS
K850959 · JAA
Advance Medical Designs, Inc.
Radiology · 32d
Cleared Apr 09, 1985
URETERAL DILATION SET
K851144 · EZN
Van-Tec, Inc.
Gastroenterology & Urology · 19d
Cleared Apr 09, 1985
GAMBRO PRESSURE MONITOR GUARDS
K851230 · FIB
Gambro, Inc.
Gastroenterology & Urology · 14d
Cleared Apr 08, 1985
BIOMEDICS BLADDER SCANNER
K842687 · ITX
Biomedics
Radiology · 272d
Cleared Apr 08, 1985
MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT
K844597
Xanmed Corp.
General & Plastic Surgery · 133d
Cleared Apr 08, 1985
KORVIN VITA RADIOPAQUE PLASTIC TEETH
K844670 · ELM
Credent Co.
Dental · 129d