Company
CME America, 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)
48recalls (0 in 12 months)
48recalls that name a 510(k)
Product codes
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) |
|---|---|---|---|
| Jul 30, 2020 | CME America, LLC CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable r Terminated |
FRN | K080954 |
| Jul 30, 2020 | CME America, LLC CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through c Terminated |
FRN | K080954 |
| Jul 30, 2020 | CME America, LLC CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptab Terminated |
FRN | K080954 |
| Jul 30, 2020 | CME America, LLC CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically accepta Terminated |
FRN | K080954 |
| Jul 30, 2020 | CME America, LLC CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically accept Terminated |
FRN | K080954 |
| Jul 30, 2020 | CME America, LLC CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable r Terminated |
FRN | K080954 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset With Female Luer, REF: A120-160XPSN Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC CMExpress Microbore Set, REF: A120-160C Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC Standard BodySet with Needleless Connectors, REF: A120-125XS Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard set with Female Luer, REF: A120-003XSN Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC CMExpress Microbore Sets, REF: A120-161C Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC CMExpress Microbore Sets, REF: A120-160C2YRV Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC CMExpress Microbore Sets, REF: A120-160CYFRV Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-160GCFA Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-125XSE Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-003XS2YV Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A100-163XSL Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A100-163XE90S Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset with Filter, REF: A100-164XESF Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset with Filter, REF: A120-160XSFE Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC CMExpress Microbore Set, REF: A120-161CYF Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC CMExpress Microbore Set, REF: A120-160CRV Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-160X2YB Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-161XPSV Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset with Filter, REF: A100-163XESF Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-161XYBS Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-161XYB Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-160XYSF Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A100-163XSFL Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-112XSFK Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-160XSFK Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-161XPS Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A100-163XES Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A100-163XESV Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard Microset, REF: A120-160XPS Terminated |
FPA | K042696 |
| Jul 15, 2020 | CME America, LLC BodyGuard BodySet, REF: A120-160SAS Terminated |
FPA | K042696 |
| Mar 18, 2020 | CME America, LLC CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress Terminated |
FRN | K061325 |
| Mar 11, 2020 | CME America, LLC BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml
Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids int Terminated |
FRN | K042696 |
| Feb 27, 2020 | CME America LLC CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/*
Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: 20 Terminated |
FRN | K042696 |
| Jan 14, 2020 | CME America, LLC BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA the Terminated |
FPA | K031749 |
| Feb 19, 2015 | CME America, LLC BodyGuard 323 pump, models
100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS,
100-603XSA and 100-603XSAP Terminated |
FRN | K042696 |