4,359 results · 26ms · Sources: EU EUDAMED, 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