33 results · 21ms · Sources: EU EUDAMED, US FDA

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SMR 140° Reverse Humeral Body

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772344130·PROTECT.PRO ACTION BACK SUPPORT BLACK XL

NA

FDA UDI
Stryker GmbH·07613154639694·Screw Marker 19,5

18M - Loggers - 18 Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588015057·18M - Loggers - 18 Metal

Blade Handle

FDA UDI
KATENA PRODUCTS, INC.·00841668112380·BARD-PARKER HANDLE #3

CLASSIC NMS

FDA 510(k)
FDA Class 2 ·Physical Medicine

HealthMammo

FDA 510(k)
FDA Class 2 ·Radiology

WAL-MART/EQUATE

FDA Adverse Event
Other ·ASO LLC·Product code KGX·August 27, 2013

DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·April 18, 2016

DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·February 3, 2016

POUNCE VENOUS THROMBECTOMY SYSTEM

FDA Adverse Event
Injury ·SURMODICS INC·Product code QEW·May 16, 2024

HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3- PRONG

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 21, 2008

MAXIMO DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011

VERSA-DIAL/COMP TI STD TAPER

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code MBF·July 2, 2013

Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use

FDA Enforcement
Class II ·Terminated·Microbiologics Inc·March 13, 2019

CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

FDA Enforcement
Class II ·Terminated·Cell Marque Corporation·June 7, 2017

LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50

FDA Enforcement
Class II ·Terminated·LeMaitre Vascular, Inc.·March 22, 2017

LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU) REF # e2400-53

FDA Enforcement
Class II ·Terminated·LeMaitre Vascular, Inc.·March 22, 2017

LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53

FDA Enforcement
Class II ·Terminated·LeMaitre Vascular, Inc.·March 22, 2017

LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51

FDA Enforcement
Class II ·Terminated·LeMaitre Vascular, Inc.·March 22, 2017