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

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CONFORMIS UNI-CONDYLAR KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ANTERIOR STABILIZED TIBIAL BEARINGS

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDPOR PTERIONAL SURGICAL IMPLANT

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

VERCISE CARTESIA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·February 19, 2024

IMP,TSV,4.1MM,SBM,13

FDA Adverse Event
Injury ·ZIMVIE US CORP LLC·Product code DZE·October 21, 2025

TERUMO ADVANCED PERFUSION SYSTEM 1

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·April 18, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 21, 2011

ATTAIN OTW

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWP·July 10, 2008

IMP,TSV,4.1MM,SBM,10

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·October 21, 2025

IMP,TSV,4.1MM,SBM,11.5

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·November 18, 2024

IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·November 1, 2023

Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter

FDA Enforcement
Class II ·Terminated·PEROUSE MEDICAL·January 7, 2015

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012