Company
GETINGE US SALES LLC
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)
12recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FSY | Light, Surgical, Ceiling Mounted | 6 |
| BSF | Absorber, Carbon-Dioxide | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 1 |
| MAL | Graft, Vascular, Synthetic/Biologic Composite | 1 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 1 |
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) |
|---|---|---|---|
| Nov 13, 2019 | GETINGE US SALES LLC Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile
REF: BEQ-HMOD 30000 Open, Classified |
DTZ | K100278 |
| Aug 22, 2019 | GETINGE US SALES LLC The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascul Terminated |
MAL | K021213 |
| Jul 22, 2019 | GETINGE US SALES LLC Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems. Terminated |
BSF | None listed |
| Jun 5, 2019 | GETINGE US SALES LLC PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0.
Usage:
The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monit Terminated |
DXG | K172259 |
| Mar 20, 2019 | GETINGE US SALES LLC Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg
Product Code/REF Number: 6685775
Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode ar Terminated |
PIF | K153688 |
| Mar 7, 2019 | GETINGE US SALES LLC Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number ARD2SAT00130A
Product Usage:
This product is designed to support one or two medical grade flat screen(s) alone or in a Terminated |
FSY | None listed |
| Mar 7, 2019 | GETINGE US SALES LLC Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400150A
Product Usage:
This product is designed to support one or two medical grade flat screen(s) alo Terminated |
FSY | None listed |
| Mar 7, 2019 | GETINGE US SALES LLC Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Part Number ARD268400140A
Product Usage:
This product is designed to support one or two medical grade flat screen(s) alone or Terminated |
FSY | None listed |
| Mar 7, 2019 | GETINGE US SALES LLC Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A
Product Usage:
This product is designed to support one or two medical grade flat screen(s) alone or in associati Terminated |
FSY | None listed |
| Apr 10, 2018 | GETINGE US SALES LLC VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911
ARD568811951, ARD568811961
The device is designed to illuminate the body of a Terminated |
FSY | K130513 |
| Mar 20, 2018 | GETINGE US SALES LLC HEMASHIELD Knitted Double Velour Cardiovascular Fabric Terminated |
DXZ | K955349 |
| Mar 5, 2018 | GETINGE US SALES LLC ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094 Terminated |
FSY | K040735 |