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MOLDCARE RI II

FDA UDI
ALCARE CO., LTD.·04900070959429·website https://www.alcare.co.jp/en/medical/pro...

HNC-127 NEUROVASCULAR ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

MODEL HNC NEUROVASCULAR ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

HNC-63-INT NEUROVASCULAR ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

HNC-127-TRIO NEUROVASCULAR ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

CURE PRODUCTS

FDA Adverse Event
Malfunction ·CONVATEC INC·Product code KOD·March 29, 2023

ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 1, 2025

CURE PRODUCTS

FDA Adverse Event
Malfunction ·CONVATEC INC·Product code KOD·March 29, 2023

SAFEKO NITRILE STANDARD EXAM GRADE GLOVE

FDA Adverse Event
Malfunction ·UNK·Product code LZA·March 22, 2022

COMPAT PUMP

FDA Adverse Event
Injury ·NOVARTIS NUTRITION CORP·Product code LZH·August 10, 2000

PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

FDA Adverse Event
Injury ·WILSON-COOK MEDICAL INC·Product code KNT·June 23, 2022

PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code KNT·June 30, 2022

PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

FDA Adverse Event
Injury ·WILSON-COOK MEDICAL INC·Product code KNT·May 20, 2022

CURE PRODUCTS

FDA Adverse Event
Injury ·CONVATEC·Product code EZD·October 30, 2024

UNKNOWN HIP FEMORAL STEM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KXA·November 13, 2019

UNKNOWN HIP FEMORAL STEM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 12, 2019

UNKNOWN HIP FEMORAL AUGMENT

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 13, 2019

UNKNOWN HIP FEMORAL AUGMENT

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 12, 2019

MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.

FDA Enforcement
Class II ·Terminated·MedtestDx, Inc.·September 23, 2015