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

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TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526780781·LEVAMED ACTIVE ANKLE SUP SLVR L VI

Mini Sprint ®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70612261·Mini Sprint II Brackets FACE Evolution II Syste...

DynaNail

FDA UDI
Medshape, Inc.·M97012000612260·DYNANAIL, 12 X 260MM

CALIBRATOR FOR AUTOMATED SYSTEMS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SMARTMONITOR 2 PS

FDA Adverse Event
Malfunction ·PHILLIPS RESPIRONICS - CHMV·Product code FLS·February 21, 2014

SMART MONITOR 2 PS

FDA Adverse Event
Malfunction ·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 21, 2026

PROMUS ELEMENT ?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 16, 2013

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 19, 2008

COLLEAGUE CXE VOLUMETRIC INFUSION PUMP SINGLE CHANNEL RECERT

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 18, 2011

LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·October 7, 2013

SMARTMONITOR 2 PROFESSIONAL SERIES

FDA Adverse Event
Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code FLS·August 23, 2013

SMART MONITOR 2 PS

FDA Adverse Event
Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013

SMART MONITOR 2 PS

FDA Adverse Event
Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·September 4, 2013

SMART MONITOR 2 PS

FDA Adverse Event
Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·October 11, 2013

Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015