Medical Device Manufacturer · US , Indianapolis , IN

Promex, Inc. - FDA 510(k) Cleared Devices

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.

FDA 510(k) Regulatory Record - Promex, Inc.
18 devices
1-18 of 18
Cleared Dec 19, 2002
BIOPSY SITE TISSUE MARKER DEVICE
K023450 · NEU
General & Plastic Surgery · 65d
Cleared Nov 06, 2002
CO-AXIAL INTRODUCER NEEDLE
K022634 · DYB
Cardiovascular · 90d
Cleared Jul 24, 2001
VACUUM ASSISTED CORE BIOPSY DEVICE
K010400 · KNW
Gastroenterology & Urology · 162d
Cleared Jun 22, 2001
AUTOMATED CORE BIOPSY DEVICE
K011270 · FCG
Gastroenterology & Urology · 57d
Cleared May 01, 2000
BONE BIOPSY NEEDLE
K001132 · KNW
Gastroenterology & Urology · 21d
Cleared Jan 07, 2000
AUTOMATED CORE BIOPSY DEVICE
K994272 · KNW
Gastroenterology & Urology · 18d
Cleared Dec 06, 1999
MANUAL BONE MARROW BIOPSY DEVICE
K993435 · KNW
Gastroenterology & Urology · 55d
Cleared Nov 21, 1997
PROSTATE SEEDING NEEDLE
K973184 · IWJ
Radiology · 88d
Cleared Sep 29, 1997
PROMEX ENT TISSUE REMOVAL SYSTEM
K972865 · ERL
Ear, Nose, Throat · 56d
Cleared Jun 14, 1996
AUTOMATED VITRECTOMY DEVICE
K961078 · HQE
Ophthalmic · 88d
Cleared Mar 18, 1996
KIRSHNER WIRES (K-WIRE) & STEINMANN PINS
K960023 · JDW
Orthopedic · 76d
Cleared Feb 28, 1996
SPINAL NEEDLE
K960405 · MIA
Anesthesiology · 30d
Cleared Jan 22, 1996
SURGICAL CUTTER
K955168 · GEI
Obstetrics & Gynecology · 70d
Cleared Sep 29, 1995
TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE
K954265 · KNW
Gastroenterology & Urology · 17d
Cleared Sep 22, 1995
AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT
K954231 · FCG
Gastroenterology & Urology · 11d
Cleared Sep 12, 1995
GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE
K954155 · FCG
Gastroenterology & Urology · 7d
Cleared Dec 21, 1994
CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
K945146 · FCG
Gastroenterology & Urology · 62d
Cleared Nov 22, 1994
BREAST LESION LOCALIZATION NEEDLE
K945124 · GDF
General & Plastic Surgery · 34d
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