156 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Oridion CO2 sampling lines and water traps under the label: MicroStreamC02 Sampling Lines: FilterLine Set Adult/Pediatric -Part No: XS04620-01; FilterLine Set Adult/Pediatric (100 unit boxes)-Part No. 010579; FilterLine H Set Adult/Pediatric -Part No. XS04624 ; FilterLine H Set Adult/Pediatric (100 unit boxes) Part No: 010580; FilterLine H Set Infant/Neonatal-Part No. 006324; FilterLine Set Adult/Pediatric Long Part No. 007768; FilterLine H Set Adult/Pediatric Long Part No. 007737; FilterLine H Set Infant/Neonatal Long Part No. 007738 Smart CapnoLine Plus (O2 connector) Part No. 009818 Smart CapnoLine Plus (O2 connector) (Special 100 unit boxes) - Part No.; 010209; Smart CapnoLine Plus Long (O2 connector) Part No. 010340; Smart CapnoLine Plus Long (O2 connector) (Special 100 unit boxes) Part No: 010339; Smart CapnoLine Plus O2 (O2 tubing) Part No. 009822 Smart CapnoLine Plus O2 (O2 tubing) (Special 100 unit boxes) Part No. 010210; Smart CapnoLine Plus O2 Long (O2 tubing) Part No. 009826; Smart CapnoLine Plus O2 Long (O2 tubing) (Special 100 unit boxes) , Part No. 010341; Smart CapnoLine Pediatric Part No. 007266 Smart CapnoLine O2 Pediatric (O2 tubing) Part No. 07269; Smart CapnoLine O2 Pediatric Long (O2 tubing) Part No.007743; Smart CapnoLine H Plus O2 (O2 tubing) Part No. 010433; Smart CapnoLine H O2 Adult (O2 tubing) Part No. 010478; Smart CapnoLine H O2 Intermediate (O2 tubing) Part No; 010475; Smart CapnoLine H Pediatric (O2 connector) Part No. 010581; Smart CapnoLine H O2 Pediatric (O2 tubing) Part No. 010582 O2 CO2 Nasal FilterLine Adult (O2 connector) Part No. 010207; O2 CO2 Nasal FilterLine Adult (O2 tubing) Part No. 006912; O2 CO2 Nasal FilterLine Adult Long (O2 connector) Part No. 010342; O2 CO2 Nasal FilterLine Adult Long (O2 tubing) Part No. 007739; O2 CO2 Nasal FilterLine Pediatric (O2 tubing) Pat No. 006913; O2 CO2 Nasal FilterLine Long (O2 tubing) Part No 007740; NIV Line Adult Part No. 008174; NIV Line Pediatric Part No. 008175; Nasal FilterLine Infant/Neonatal Part No. XS0447; CapnoLine H Adult Part No. 008177; CapnoLine H Pediatric Part No. 008178; CapnoLine H Infant/Neonatal Part No. 008179; CapnoLine H O2 Adult (O2 tubing) Part No. 008180; CapnoLine H O2 Pediatric (O2 tubing) Part No. 008181; CapnoLine H O2 Infant/Neonatal (O2 tubing) Part No. 012111; VitaLine H Set Adult/Pediatric Part No. 010787; VitaLine H Set Infant/Neonatal Part No. 010807; FilterLine XL Part No. 006325; Smart CapnoLine Guardian Part No. 012528; Smart CapnoLine Guardian O2 Part No. 012529; Smart CapnoLine Guardian O2 Long Part No. 012530
FDA Recall
Terminated
·Oridion Medical·Product code CCK·February 16, 2012
Microstream CAPNOLINE H O2 ADULT 25UN Part Number: 008180
FDA Recall
Terminated
·Oridion Medical·Product code cck·May 26, 2010
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.
FDA Recall
Terminated
·Med-Hot Thermal Imaging, Inc.·Product code LHQ·January 14, 2017
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.
FDA Enforcement
Class II
·Terminated·Med-Hot Thermal Imaging, Inc.·May 17, 2017
BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 16, 2021
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 17, 2021
Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm Product Code: 58229 19US
FDA Recall
Terminated
·Prodimed Plastimed Division 3 Rue Louis Armand Le Plessis Bouchard France·Product code EOQ·May 27, 2020
Bronchofiberscope BF-40
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018
Bronchovideoscope BF-Q180-AC
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018
Bronchovideoscope F-1TQ180
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018
Ultrasonic Bronchoscope BF-UC160F-OL8
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018
Bronchofiberscope BF-XP60
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018
K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
FDA Recall
Terminated
·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code EOQ·January 4, 2021
WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices.
FDA Recall
Terminated
·ConMed Corporation·Product code EOQ·November 20, 2012
Bronchofiberscope BF-P60
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018
Rhino Laryngo scope ENF-VT2
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018
Bronchovideoscope BF-XT160
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018
BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 16, 2021
BF-P60 OES Bronchofiberscope, Model No. BF-P60
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 16, 2021
Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19
FDA Recall
Terminated
·Prodimed Plastimed Division 3 Rue Louis Armand Le Plessis Bouchard France·Product code EOQ·May 27, 2020