17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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