43 results · 23ms · Sources: EU EUDAMED, US FDA

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VACUETTE EDTA K2 TUBES

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VACUETTE BLOOD COLLECTION TUBE 3ML K2E K2EDTA

FDA Adverse Event
Malfunction ·GREINER BIO-ONE NA INC.·Product code JKA·November 2, 2020

ADVANCE®

FDA UDI
Microport Orthopedics Inc.·M684K00141041·

BOTANIQ

FDA UDI
Inspecs U.S.A., L.C.·00841543148695·SUNGLASS

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0140040·Driver Shaft, T30 Split Tip Double End Cap Starter

OSTEOBELL

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CANDELA LONG PULSE ND:YAG

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 7, 2026

HEARTSINE SAMARITAN 300P AND PAD-PAK

FDA Adverse Event
Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·April 11, 2018

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

ANTHEM RF

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011

CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL AORTIC BIOPROSTHESIS

FDA Adverse Event
Other ·EDWARDS LIFESCIENCES·Product code LWR·March 12, 2008

O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants

FDA Enforcement
Class II ·Terminated·Biomet 3i, LLC·August 24, 2016

HEARTSINE SAMARITAN 300P AND PAD-PAK

FDA Adverse Event
Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·May 13, 2019

HEARTSINE SAMARITAN 300P AND PAD-PAKV

FDA Adverse Event
Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·June 17, 2019

HEARTSINE SAMARITAN 300P AND PAD-PAK

FDA Adverse Event
Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·June 13, 2019

HEARTSINE SAMARITAN 300P AND PAD-PAK

FDA Adverse Event
Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·May 17, 2019

PACKAGE,350P,PP01,EN,350-BAS-US-10

FDA Adverse Event
Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·January 14, 2019

HEARTSINE SAMARITAN 300P AND PAD-PAK

FDA Adverse Event
Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·November 8, 2019

HEARTSINE SAMARITAN 300P AND PAD-PAK

FDA Adverse Event
Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·October 24, 2018