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

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SUTRAZORB

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

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383502702·Gutta Percha Points is used to root canal filin...

INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

EASYTRAVEL

FDA 510(k)
FDA Class 2 ·Physical Medicine

BAXANO IO-FLEX SYSTEM

FDA Adverse Event
Other ·BAXANO, INC.·Product code HAE·July 2, 2012

BRAVO

FDA Adverse Event
Malfunction ·GIVEN IMAGING LTD.·Product code FFT·May 1, 2013

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·September 19, 2014

ADJ PIN COLLET 2.0-3.2MM

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·May 20, 2011

BAXANO IO-FLEX SYSTEM

FDA Adverse Event
Other ·BAXANO, INC.·Product code HAE·July 2, 2012

BD DURASAFE¿ TRAY

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code CAZ·October 25, 2022

INSTINCT JAVA SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

INSTINCT JAVA SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

INSTINCT JAVA SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

INSTINCT JAVA ROD, UNKNOWN

FDA Adverse Event
Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

INSTINCT JAVA ROD, UNKNOWN

FDA Adverse Event
Injury ·ZIMMER SPINE·Product code MNH·October 31, 2019

INSTINCT JAVA SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER SPINE·Product code MNH·October 31, 2019

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

Model Number L231, PROPONENT DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

Model Number L101, ESSENTIO DR SL Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021