Medical Device Manufacturer · US , Oceanside , CA

Pfm Medical, Inc. - FDA 510(k) Cleared Devices

20 submissions · 17 cleared · Since 2004

Recent clearances: JetCan® Pro Safety Huber Needle, ASEPT® Glide Peritoneal Drainage System, ASEPT Peritoneal Drainage System

20
Total
17
Cleared
0
Denied

Pfm Medical, Inc. has 17 FDA 510(k) cleared medical devices. Based in Oceanside, US.

Latest FDA clearance: May 2025. Active since 2004. Primary specialty: General Hospital.

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

FDA 510(k) Regulatory Record - Pfm Medical, Inc.

20 devices
1-20 of 20
Cleared May 02, 2025
JetCan® Pro Safety Huber Needle
K242763 · FPA
General Hospital · 232d
Cleared Jan 14, 2025
ASEPT® Glide Peritoneal Drainage System
K241278 · PNG
Gastroenterology & Urology · 253d
Cleared May 02, 2023
ASEPT Peritoneal Drainage System
K221779 · PNG
Gastroenterology & Urology · 315d
Cleared Oct 06, 2022
NuCath Wedge Pressure Catheter
K213666 · DQO
Cardiovascular · 318d
Cleared Aug 19, 2020
Asept Surgical Face Mask
K201137 · FXX
General Hospital · 113d
Cleared Oct 28, 2019
primeMidline Catheters
K192802 · PND
General Hospital · 28d
Cleared Mar 07, 2018
primeMidline Catheters
K173114 · PND
General Hospital · 159d
Cleared Mar 25, 2014
SAFETY BIOPSY NEEDLE SYSTEM
K140137 · FCG
Gastroenterology & Urology · 62d
Cleared Jul 16, 2013
LPP (LOW PROFILE PORT)
K122402 · LJT
General Hospital · 343d
Cleared Mar 13, 2012
VETA PERITONEAL DIALYSIS CATHETER
K113354 · FJS
Gastroenterology & Urology · 120d
Cleared Sep 21, 2011
TRIPLE LUMEN PFM PICC
K110914 · LJS
General Hospital · 173d
Cleared Feb 26, 2010
ASEPT PERITONEAL DRAINAGE SYSTEM
K093796 · PNG
Gastroenterology & Urology · 77d
Cleared Nov 06, 2009
ASEPT PLEURAL DRAINAGE SYSTEM
K093307 · DWM
Anesthesiology · 15d
Cleared Mar 19, 2009
PICC (CT RATED AND NON-RATED)
K083873 · LJS
General Hospital · 80d
Cleared Mar 07, 2008
JET PORT PLUS HP CATHETER SYSTEM
K072481 · LJT
General Hospital · 185d
Cleared Dec 12, 2007
MODIFICATION TO: T-PORT HP INFUSION PORT
K073210 · LJT
General Hospital · 28d
Cleared Nov 19, 2007
PFM PICC
K072391 · LJS
General Hospital · 87d
Cleared Oct 17, 2007
T-PORT HP INFUSION PORT
K071993 · LJT
General Hospital · 89d
Cleared Aug 30, 2007
MODIFICATION TO EZ HUBER SAFETY INFUSION SET
K071846 · FPA
General Hospital · 56d
Cleared Sep 17, 2004
EZ HUBER SAFETY INFUSION SET
K040533 · FPA
General Hospital · 200d
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