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

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DMi Dental Implant System

FDA 510(k)
FDA Class 2 ·Dental

VIVID POST DRILL

FDA UDI
BIOLOREN SRL·08056099233449·Cylindrical drill kit ass.(4 drills)

Mariner Cortical

FDA UDI
Seaspine Orthopedics Corporation·10889987168340·CORTICAL SHANK, Cannulated, 6.0 X 60

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319705346·Webster Needle Holder 5" (12.5cm), serrated jaws

Mariner Cortical

FDA UDI
Seaspine Orthopedics Corporation·10889981168346·CORTICAL SHANK, Cannulated, 6.0 X 60

ESI

FDA UDI
FTT MEDICAL, INC.·B3961600600·YANKAUER SUCTION, STANDARD SIZE. ACMI FITTING.

ARTHREX ANGEL PRP KIT (US TRAY)

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code ORG·June 23, 2023

Apelo® / Apelo® MIS

FDA UDI
ATLAS SPINE, INC.·M68111001600600·5.5mm x 60mm MIS Contoured Rod

GBR System

FDA UDI
Surgident Co.,Ltd.·08800041000104·

Canaveral®

FDA UDI
FLOSPINE LLC·B183121600600·6.0mm Straight Rod, Ti Alloy 60mm

EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BIOGRAPH 6

FDA 510(k)
FDA Class 2 ·Radiology

PROTECTA XT DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·October 10, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 10, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011

SERIES PATELLA THIN 3-PEG

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018

VANGUARD FEMORAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018

CC CRUCIATE TRAY

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018

DUO FLUID CART WITH SMOKE EVACUATOR

FDA Adverse Event
Malfunction ·DORNOCH·Product code JCX·September 17, 2019

MAGNETOM Verio Dot. Model Number: 10684333.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025