41 results
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8ms
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Sources: EU EUDAMED, US FDA
CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
FDA Enforcement
Class I
·Terminated·CME America, LLC·March 25, 2020
Plastic Pack Customed, code 900-2582 (1) GOWN LGE SMS IMP REINF L/F (1) GOWN SURG. REINF LGE TMJRAP LIF (1) MAYO STAND COVER REINF LIF (1) TABLE COVER REINF 50" X 90" LIF (4) (1) PVP PAINT 8" STICK SPONGE (2) DRAPESHEET 41X A¿MED LIF (3) TOWELS ABSORBENT 15 X 20 LIF (2)DRAPE UTILITY Rape LIF (1) BLADE SURGICAL15 S/STEEL (10) GAUZE SPONGE 4 X 4 16 PL Y (20) APPLICATOR COTOIN 6 WOOD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
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 intravenously.
FDA Enforcement
Class I
·Terminated·CME America, LLC·March 18, 2020
BodyGuard Microset with Filter, REF: A120-160XSFE
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset, REF: A120-003XS2YV
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset, REF: A120-112XSFK
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
Standard BodySet with Needleless Connectors, REF: A120-125XS
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset, REF: A120-160GCFA
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset, REF: A120-161XYB
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
CMExpress Microbore Sets, REF: A120-160C2YRV
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
CMExpress Microbore Sets, REF: A120-161C
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset, REF: A100-163XESV
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard BodySet, REF: A120-160SAS
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
CMExpress Microbore Set, REF: A120-160C
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard set with Female Luer, REF: A120-003XSN
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
CMExpress Microbore Set, REF: A120-161CYF
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset with Filter, REF: A100-163XESF
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020