59 results
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14ms
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Sources: EU EUDAMED, US FDA
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
FDA Enforcement
Class II
·Terminated·Atos Medical AB·May 19, 2021
1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.
FDA Enforcement
Class II
·Terminated·AB ULAX·October 14, 2020
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
FDA Enforcement
Class III
·Terminated·Arc Medical Inc·May 20, 2015
Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
FDA Enforcement
Class II
·Terminated·Intersurgical Inc·July 4, 2018
STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·April 13, 2016
STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·April 13, 2016
CA500 Epix Universal Clip Applier Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·April 13, 2016
STD KIT GK260, Standard Set 360 Z Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·April 13, 2016
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
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
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
FDA Enforcement
Class II
·Terminated·CME America, LLC·February 25, 2015
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 therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments.
FDA Enforcement
Class II
·Terminated·CME America, LLC·May 13, 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