15 results · 20ms · Sources: EU EUDAMED, US FDA

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NUVASIVE LATERAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Gen. Acces/ Instr. Tip Guard

FDA UDI
KATENA PRODUCTS, INC.·00841668112335·SURG-I-BAND LIME GREEN

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450053324·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450217757·

PARADIGM QUICK-SET INFUSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

PCCS GRAFT DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 17, 2025

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·March 17, 2016

DPM 6/7 MONITOR

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014

GPS PROCEDURAL STRETCHER

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FPO·May 12, 2011

LEGION PS OXIN FEM SZ5 LT

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018

GII OVAL RESURFACING PAT 32MM

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·December 18, 2015

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

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