ClearanceBrief
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

CodeDeviceRecords
FPASet, Administration, Intravascular38
FRNPump, Infusion10

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Jul 30, 2020CME 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
FRNK080954
Jul 30, 2020CME 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
FRNK080954
Jul 30, 2020CME 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
FRNK080954
Jul 30, 2020CME 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
FRNK080954
Jul 30, 2020CME 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
FRNK080954
Jul 30, 2020CME 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
FRNK080954
Jul 15, 2020CME America, LLC
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset With Female Luer, REF: A120-160XPSN
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
CMExpress Microbore Set, REF: A120-160C
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
Standard BodySet with Needleless Connectors, REF: A120-125XS
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard set with Female Luer, REF: A120-003XSN
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
CMExpress Microbore Sets, REF: A120-161C
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
CMExpress Microbore Sets, REF: A120-160C2YRV
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
CMExpress Microbore Sets, REF: A120-160CYFRV
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-160GCFA
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-125XSE
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-003XS2YV
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A100-163XSL
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A100-163XE90S
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset with Filter, REF: A100-164XESF
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset with Filter, REF: A120-160XSFE
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
CMExpress Microbore Set, REF: A120-161CYF
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
CMExpress Microbore Set, REF: A120-160CRV
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-160X2YB
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-161XPSV
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset with Filter, REF: A100-163XESF
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-161XYBS
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-161XYB
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-160XYSF
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A100-163XSFL
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-112XSFK
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-160XSFK
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-161XPS
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A100-163XES
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A100-163XESV
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard Microset, REF: A120-160XPS
Terminated
FPAK042696
Jul 15, 2020CME America, LLC
BodyGuard BodySet, REF: A120-160SAS
Terminated
FPAK042696
Mar 18, 2020CME 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
FRNK061325
Mar 11, 2020CME 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
FRNK042696
Feb 27, 2020CME 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
FRNK042696
Jan 14, 2020CME 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
FPAK031749
Feb 19, 2015CME America, LLC
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
Terminated
FRNK042696
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