Medical Device Manufacturer · US , Indianapolis , IN

Promex, Inc.

18 submissions · 18 cleared · Since 1994
18
Total
18
Cleared
0
Denied

Promex, Inc. has 18 FDA 510(k) cleared medical devices. Based in Indianapolis, US.

Historical record: 18 cleared submissions from 1994 to 2002. Primary specialty: Gastroenterology & Urology.

Browse the FDA 510(k) cleared devices submitted by Promex, Inc. Filter by specialty or product code using the sidebar.

18 devices
1–12 of 18
BIOPSY SITE TISSUE MARKER DEVICE
K023450 · NEU Marker, Radiographic, Implantable · General & Plastic Surgery
Dec 2002 65d
CO-AXIAL INTRODUCER NEEDLE
K022634 · DYB Introducer, Catheter · Cardiovascular
Nov 2002 90d
VACUUM ASSISTED CORE BIOPSY DEVICE
K010400 · KNW Instrument, Biopsy · Gastroenterology & Urology
Jul 2001 162d
AUTOMATED CORE BIOPSY DEVICE
K011270 · FCG Biopsy Needle · Gastroenterology & Urology
Jun 2001 57d
BONE BIOPSY NEEDLE
K001132 · KNW Instrument, Biopsy · Gastroenterology & Urology
May 2000 21d
AUTOMATED CORE BIOPSY DEVICE
K994272 · KNW Instrument, Biopsy · Gastroenterology & Urology
Jan 2000 18d
MANUAL BONE MARROW BIOPSY DEVICE
K993435 · KNW Instrument, Biopsy · Gastroenterology & Urology
Dec 1999 55d
PROSTATE SEEDING NEEDLE
K973184 · IWJ System, Applicator, Radionuclide, Manual · Radiology
Nov 1997 88d
PROMEX ENT TISSUE REMOVAL SYSTEM
K972865 · ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · Ear, Nose, Throat
Sep 1997 56d
AUTOMATED VITRECTOMY DEVICE
K961078 · HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered · Ophthalmic
Jun 1996 88d
KIRSHNER WIRES (K-WIRE) & STEINMANN PINS
K960023 · JDW Pin, Fixation, Threaded · Orthopedic
Mar 1996 76d
SPINAL NEEDLE
K960405 · MIA Needle, Spinal, Short Term · Anesthesiology
Feb 1996 30d
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All18 Gastroenterology & Urology 9 General & Plastic Surgery 2 Anesthesiology 1 Radiology 1 Obstetrics & Gynecology 1 Ophthalmic 1 Cardiovascular 1 Orthopedic 1 Ear, Nose, Throat 1