Company ยท IL
Elcam Medical Acal
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2023. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FMG | Stopcock, I.V. Set | 8 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| DQX | Wire, Guide, Catheter | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 |
| FMF | Syringe, Piston | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| KZH | Introducer, Syringe Needle | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 25, 2023 | K231900 | A-TAP (previously called Arthrotap) Elcam Medical Acal, IL | FMF |
| Sep 15, 2022 | K211204 | SafePort(TM) Manifold (or Stopcock) Elcam Medical Acal, IL | FMG |
| Apr 23, 2019 | K190489 | Elcam Stopcocks and Manifolds Elcam Medical Acal, IL | FMG |
| Jul 30, 2014 | K141254 | ELCAM STOPCOCKS AND MANIFOLDS Elcam Medical Acal, IL | FMG |
| May 23, 2013 | K123084 | DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD Elcam Medical Acal, IL | FMG |
| Jul 16, 2012 | K120253 | ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) Elcam Medical Acal, IL | DRG |
| Jun 8, 2012 | K120624 | ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) Elcam Medical Acal, IL | DRS |
| Feb 9, 2012 | K111467 | FLEXI-Q DV AND DVR AUTO-INJECTORS Elcam Medical Acal, IL | KZH |
| Jun 9, 2011 | K111016 | SAFEPORT MANIFOLD (TM) (OR STOPCOCK) Elcam Medical Acal, IL | FPA |
| Jun 17, 2010 | K100425 | HASKAL TORQUE DEVICE Elcam Medical Acal, IL | DQX |
| Oct 2, 2008 | K082106 | ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) Elcam Medical Acal, IL | FMG |
| Jun 29, 2006 | K060759 | Y-CLICK CONNECTOR Elcam Medical Acal, IL | DTL |
| May 11, 2006 | K053405 | BACSTOP Elcam Medical Acal, IL | FMG |
| Apr 13, 2006 | K060231 | CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK Elcam Medical Acal, IL | FMG |
| Jun 30, 2004 | K034043 | H-FLOW VALVE Elcam Medical Acal, IL | DQO |
| Sep 12, 2003 | K032393 | INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) Elcam Medical Acal | FMG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||