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Panels › Anesthesiology › Product code BYD · Class 1

Condenser, Heat And Moisture (Artificial Nose)

Regulation 868.5375

0510(k)s in 12 months (73 all time)
0recalls in 12 months (15 all time)
4recalls that name a 510(k)
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Top companies in BYD

Company510(k)sRecalls
Icor AB90
Gibeck, Inc.70
Gibeck Respiration60
Smiths Medical ASD Inc.06
Artema Medical AB50
Mallinckrodt Medical50
Flocare Medical40
Intertech Resources, Inc.40
TELEFLEX MEDICAL INC04
Pharma Systems, Inc.30
DateFirm and productCodeLinked 510(k)
Oct 23, 2024Smiths Medical ASD Inc.
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Open, Classified		 BYDNone listed
Oct 23, 2024Smiths Medical ASD Inc.
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Open, Classified		 BYDNone listed
Oct 23, 2024Smiths Medical ASD Inc.
smiths medical portex, Y' PIECE 15MM, REF 100/276/000
Open, Classified		 BYDNone listed
Apr 11, 2022TELEFLEX MEDICAL INC
(1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061,
Open, Classified		 BYDNone listed
Mar 29, 2021Atos Medical AB
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
Terminated		 BYDNone listed
Sep 4, 2020AB ULAX
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 dependen
Terminated		 BYDNone listed
Aug 29, 2016Teleflex Medical
MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
Terminated		 BYDNone listed
Aug 9, 2016Teleflex Medical
Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created open
Terminated		 BYDNone listed
May 9, 2015Arc Medical Inc
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
Terminated		 BYDK903054
Feb 6, 2015Teleflex Medical
MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned
Terminated		 BYDNone listed
Feb 6, 2015Teleflex, Inc.
MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgical
Terminated		 BYDNone listed
Jul 30, 2011Vital Signs Devices, a GE Healthcare Company
Vital Signs- A GE Healthcare Company - Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit; GE Medical Systems SCS 283 rue de la Miniere 78530 BUC, France p +33.1.30.70.40.40; Vital Si
Terminated		 BYDNone listed
Jul 22, 2004Smiths Medical ASD, Inc.
Thermovent 1200, Heat and Moisture Exchanger Catalog # 580021
Terminated		 BYDK874597
Jul 22, 2004Smiths Medical ASD, Inc.
ThermovenT 600, Heat and Moisture Exchangers Catalog # 580011
Terminated		 BYDK874597
Jul 22, 2004Smiths Medical ASD, Inc.
Portex Thermovent T, Heat and Moisture Exchangers Catalog # 570016;
Terminated		 BYDK874597

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