161 results
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15ms
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Sources: EU EUDAMED, US FDA
LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED L/F (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TUR Y SET, 2LEAD L/F (4) DRAPE UTILITY WITH TAPE LIF (1) TROCAR ENDO. XCEL DILATING TIP 5mm (K5LT) (1) ULTRA VERES NEEDLE 120mm (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (1) DRAPE LAP. ABDOM. WITH POUCH 102" X 122" X 78" (2) DRAPE SHEET 41" X 58" SMS (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD L/F (5) LAP SPONGE PREWASH XRD LIF (1 ) DRAPE LASER CAMERA W/EL. 6" X 96" LIF (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) TROCAR ENDOPATH XCEL DILATING TIP 11mm (K1 1LT) (1) TUBING INSUFLATION SET W/0 RING ADAPTOR LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) TABLE COVER REINFORCED 50" X 90" LIF 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
Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or non-invasively, to patients who require the followingtypes of ventilator support: Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask or nasal prongs). Assist/ Control, SIMV or Spontaneous modes of ventilation
FDA Enforcement
Class I
·Terminated·COVIDIEN LLC·December 26, 2018
Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, VN2000, VN3000, VN4000, VN5000, VT1000 , VN2102, VN2002. Emergency manual resuscitator for the Pediatric Population.
FDA Enforcement
Class I
·Terminated·Ventlab LLC·July 9, 2014
Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R
FDA Enforcement
Class I
·Terminated·Covidien LLC·October 22, 2014
MediChoice¿ Multifunction Electrode Part Number: MC171 OH
FDA Enforcement
Class I
·Terminated·Covidien LLC·October 22, 2014
Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A
FDA Enforcement
Class I
·Terminated·Covidien LLC·October 22, 2014
Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006
FDA Enforcement
Class I
·Terminated·Covidien LLC·October 22, 2014
Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660
FDA Enforcement
Class I
·Terminated·Covidien LLC·October 22, 2014
Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected Part Number: 22660PC
FDA Enforcement
Class I
·Terminated·Covidien LLC·October 22, 2014
Puritan Bennett 980 Series Ventilator, 980A1ENNISB
FDA Enforcement
Class I
·Terminated·Covidien Llc·December 15, 2021
Puritan Bennett 980 Series Ventilator, 980S3ENDICU
FDA Enforcement
Class I
·Terminated·Covidien Llc·December 15, 2021
Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
FDA Enforcement
Class I
·Terminated·Covidien Llc·December 15, 2021
Puritan Bennett 980 Series Ventilator, 980X1ENNISB
FDA Enforcement
Class I
·Terminated·Covidien Llc·December 15, 2021
Puritan Bennett 980 Series Ventilator, 980A3ENNISB
FDA Enforcement
Class I
·Terminated·Covidien Llc·December 15, 2021
Puritan Bennett 980 Series Ventilator, 980U3ESDIUU
FDA Enforcement
Class I
·Terminated·Covidien Llc·December 15, 2021
Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
FDA Enforcement
Class I
·Terminated·Covidien Llc·December 15, 2021
Puritan Bennett 980 Series Ventilator,980X1ENAIQC
FDA Enforcement
Class I
·Terminated·Covidien Llc·December 15, 2021
Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
FDA Enforcement
Class I
·Terminated·Covidien Llc·December 15, 2021
Puritan Bennett 980 Series Ventilator, 980X3JADIJJ
FDA Enforcement
Class I
·Terminated·Covidien Llc·December 15, 2021
Puritan Bennett 980 Series Ventilator, 980X1JADIJJ
FDA Enforcement
Class I
·Terminated·Covidien Llc·December 15, 2021