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

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INFILTRATION KIT

FDA 510(k)
FDA Class 2 ·Dental

ACE

FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950017140·SPREADER JAW MAUNDER SCREW WOOD 4" 10CM

Marienfeld Superior

FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317300034·

OsteoMed

FDA UDI
OSTEOMED LLC·00845694033114·5mm Chin Plate

SAVANNAH-T

FDA UDI
SPINAL ELEMENTS·00840916150013·SAVANNAH®-T SMALL T-HANDLE

ELMED

FDA UDI
ELMED INCORPORATED·00842180156531·JORDAN-VERNICK 3 PRONG RETRACTOR, W/ROTATIONAL ...

STRYKER WIRE COLLET

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY·Product code HRX·November 21, 2024

STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

ADVIA CENTAUR XP HBC TOTAL (HBCT)

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LOM·June 18, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 8, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·September 18, 2014

SM104 M-SERIES W/5TH WHEEL

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·May 16, 2011

LATITUDE ELBOW ANATOMIC HUMERAL SPOOL SZ PETIT+ SIDE GAUCHE

FDA Adverse Event
Injury ·TORNIER INC·Product code JDC·May 7, 2024

SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

FDA Enforcement
Class II ·Terminated·CME America, LLC·December 9, 2020

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025