Medical Device Manufacturer · US , Phoenix , AZ

Elcam Medical Acal - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2003

Recent clearances: A-TAP (previously called Arthrotap), SafePort(TM) Manifold (or Stopcock), Elcam Stopcocks and Manifolds

16
Total
16
Cleared
0
Denied

Elcam Medical Acal has 16 FDA 510(k) cleared medical devices. Based in Phoenix, US.

Last cleared in 2023. Active since 2003. Primary specialty: General Hospital.

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

510(k) submissions have been managed by Eleam Medical A.C.A.L as regulatory consultant.

FDA 510(k) Regulatory Record - Elcam Medical Acal

16 devices
1-16 of 16
Cleared Jul 25, 2023
A-TAP (previously called Arthrotap)
K231900 · FMF
General Hospital · 27d
Cleared Sep 15, 2022
SafePort(TM) Manifold (or Stopcock)
K211204 · FMG
General Hospital · 511d
Cleared Apr 23, 2019
Elcam Stopcocks and Manifolds
K190489 · FMG
General Hospital · 54d
Cleared Jul 30, 2014
ELCAM STOPCOCKS AND MANIFOLDS
K141254 · FMG
General Hospital · 77d
Cleared May 23, 2013
DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP...
K123084 · FMG
General Hospital · 234d
Cleared Jul 16, 2012
ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)
K120253 · DRG
Cardiovascular · 171d
Cleared Jun 08, 2012
ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
K120624 · DRS
Cardiovascular · 99d
Cleared Feb 09, 2012
FLEXI-Q DV AND DVR AUTO-INJECTORS
K111467 · KZH
General Hospital · 259d
Cleared Jun 09, 2011
SAFEPORT MANIFOLD (TM) (OR STOPCOCK)
K111016 · FPA
General Hospital · 58d
Cleared Jun 17, 2010
HASKAL TORQUE DEVICE
K100425 · DQX
Cardiovascular · 121d
Cleared Oct 02, 2008
ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
K082106 · FMG
General Hospital · 69d
Cleared Jun 29, 2006
Y-CLICK CONNECTOR
K060759 · DTL
Cardiovascular · 100d
Cleared May 11, 2006
BACSTOP
K053405 · FMG
General Hospital · 155d
Cleared Apr 13, 2006
CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED...
K060231 · FMG
General Hospital · 73d
Cleared Jun 30, 2004
H-FLOW VALVE
K034043 · DQO
Cardiovascular · 184d
Cleared Sep 12, 2003
INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
K032393 · FMG
General Hospital · 39d
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