Company
ICU Medical de Mexico, S.A. de C.V.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
20recalls (0 in 12 months)
20recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FMG | Stopcock, I.V. Set | 20 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer. Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Valve, Clamp, Rotating Luer. Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer. Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer. Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext. Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer. Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check Valve, Rotating Luer. Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer. Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2 MicroClave Clear, Clamp, Rotating Luer. Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer. Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer. Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer. Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer. Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer. Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, ster Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids f Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids Terminated |
FMG | K964435 |
| Mar 1, 2018 | ICU Medical de Mexico, S.A. de C.V. 20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids fro Terminated |
FMG | K964435 |