13 results · 22ms · Sources: EU EUDAMED, US FDA

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ENTACT SEPTAL STAPLER, MODEL 610-00100

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

Centaur Pedicle Screw System

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215127107·

HL168T

FDA 510(k)
FDA Class 2 ·Cardiovascular

ADC PEDIATRIC

FDA 510(k)
FDA Class 2 ·Radiology

STYLE 68 SALINE FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FWM·June 10, 2025

WALLFLEX DUODENAL

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MUM·January 22, 2025

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013

MP30 INTELLIVUE PATIENT MONITOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·April 28, 2011

AFFINITY BED

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code HDD·July 23, 2008

MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 9, 2025

Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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