4,359 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SlimLine
FDA UDI
Gyrus ACMI, LLC·00821925006676·SlimLine Self-Dilating Autoclavable Operating S...
NA
FDA UDI
Fehling Instruments GmbH & Co. KG·04058749000184·Ball joint adapter with excenter, fixation for ...
NA
FDA UDI
Fehling Instruments GmbH & Co. KG·04058749045208·Fixation device for MRN-3 atrial retractor,angled
SlimLine
FDA UDI
Gyrus ACMI, LLC·00821925010970·SlimLine Self-Dilating Autoclavable Operating S...
SlimLine
FDA UDI
Gyrus ACMI, LLC·00821925009295·SlimLine Self-Dilating Autoclavable Operating S...
NA
FDA UDI
Fehling Instruments GmbH & Co. KG·04058749045185·Blades (pair) f. MRP-1, fenestrated, 70 x 35 mm
NA
FDA UDI
Fehling Instruments GmbH & Co. KG·04058749045215·Fixation device for MRN-3 atrial retractor,angled
MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
QUEST LABS HAIR DRUG TEST 37000N
FDA Adverse Event
Injury
·QUEST PRODUCTS, INC.·Product code DKZ·November 22, 2023
AMERIWATER DIALYSIS RO+ SYSTEM
FDA Adverse Event
Malfunction
·AMERIWATER·Product code FIP·March 29, 2002
75H - Class A MRO - 2 Shelf Cabinet
FDA UDI
Certified Safety Manufacturing, Inc.·00766588170343·75H - Class A MRO - 2 Shelf Cabinet
75H - Class A 21 MRO - 2S Refill
FDA UDI
Certified Safety Manufacturing, Inc.·00766588629346·75H - Class A 21 MRO - 2S Refill
75H - Class A MRO 21 - w/Select Logo
FDA UDI
Certified Safety Manufacturing, Inc.·00766588620343·75H - Class A MRO 21 - w/Select Logo
AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AMERIWATER MRO PORTABLE RO SYSTEM
FDA Adverse Event
Malfunction
·AMERIWATER·Product code FIP·August 6, 2012
MRO-6 MICRO OPERATING URETEROSCOPE
FDA Adverse Event
Malfunction
·CIRCON ACMI·Product code FGB·July 28, 1999
USA MRO-7 INTEGRAL OPERATING URETEROSCOPE
FDA Adverse Event
Malfunction
·CIRCON ACMI·Product code FGB·March 24, 1998
AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers.
FDA Enforcement
Class II
·Terminated·AmeriWater Inc·September 12, 2012
USA SERIES MRO-7 INTEGRAL OPERATING URETEROSCOPE
FDA Adverse Event
Malfunction
·CIRCON ACMI·Product code FGB·March 23, 2001
AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers.
FDA Recall
Terminated
·AmeriWater Inc·Product code FIP·August 9, 2012