114 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Cidexplus Solution Test Strips
FDA Recall
Terminated
·Advanced Sterilization Products·Product code JOJ·March 16, 2005
Cidex Plus Test Strips
FDA Recall
Terminated
·Advanced Sterilization Products·Product code JOJ·December 17, 2003
Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm
FDA Enforcement
Class II
·Terminated·Angiotech (Manan Medical Products, Inc.)·February 13, 2019
Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZI·April 26, 2013
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code MEC·January 16, 2020
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 07340153700253, 07340153700260, 07340153700277 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfectors. The automated loading/unloading systems in no way affect the cleaning/disinfection performance of the washer-disinfector. The automated loading/unloading equipment is considered an accessory to the medical washer-disinfector.
FDA Recall
Terminated
·Getinge Disinfection Ab Ljungadalsgatan·Product code MEC·March 2, 2018
Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments, such as forceps and clamps, theatre shoes, and other similar and related articles found in healthcare facilities.
FDA Recall
Terminated
·Steris Corporation·Product code MEC·December 11, 2020
Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden.
FDA Recall
Terminated
·Getinge/Castle, Inc.·Product code MEC·March 25, 2003
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code MEC·February 10, 2020
Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theater shoes and other miscellaneous reusable items used in the care of patients.
FDA Recall
Terminated
·Steris Corporation·Product code MEC·June 30, 2014
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code MEC·May 20, 2019
Reliance Synergy Washer/Disinfector
FDA Recall
Terminated
·Steris Corporation·Product code MEC·April 22, 2022
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code MEC·May 20, 2019
The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items used in the care of patients at healthcare facilities / Crated for shipping.
FDA Recall
Terminated
·Steris Corporation·Product code MEC·July 14, 2012
Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128
FDA Recall
Terminated
·Getinge USA Inc·Product code MEC·May 25, 2012
GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
FDA Recall
Terminated
·Getinge Disinfection Ab Ljungadalsgatan·Product code MEC·November 26, 2014
AMSCO 5000 Series Washer/Disinfector Model # 5052
FDA Recall
Terminated
·Steris Corporation·Product code MEC·December 20, 2018
Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, The Vision Single Chamber Washer is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments such as forceps and clamps, theatre shoes and other similar and related articles found in healthcare facilities.
FDA Recall
Terminated
·Steris Corporation·Product code MEC·May 9, 2011
AMSCO 3000 Series Washer/Disinfector Model # 3052
FDA Recall
Terminated
·Steris Corporation·Product code MEC·December 20, 2018
The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment by killing vegetative bacteria and viruses, in a hot water bath at ~160 - ~170 F for 30 minutes. Catalog Number/Description: 007168 PM3500 ASSY (15KW 208/120V) 007169 PM3000 ASSY (9KW 208/120V) 007169R PM3 (9KW 208/120) REFURB 007170 PM3 ASSY (8.3KW 200V DELTA) 007171 PM3 ASSY (9KW 220V SING PH) 52640 PASTEURMATIC 3000 W/O BASKETS 52640R PM 3000 w/o Baskets Refurb 52640-200 PM 3000 W/O BASKETS 200V 52640-220 PM 3000 W/O BASKETS 220V 52641 PASTEURMATIC 3000 W/BASKET S 52641R PM 3000 w/ Baskets Refurb 52641-200 PM 3000 W BASKETS 200V 52641-220 PM 3000 W/ BASKETS 220V 52650 PASTEURMATIC 3500 W/O BASKET 52651 PASTEURMATIC 3500 W/BASKETS S
FDA Recall
Terminated
·Natus Medical Incorporated·Product code MEC·May 22, 2017