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

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VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX

FDA 510(k)
FDA Class 2 ·General Hospital

Neodent

FDA UDI
JJGC Indústria e Comércio de Materiais Dentários S/A.·07899878046981·NGS REGULAR TAPERED DRILL

Zethon

FDA UDI
ZETHON LIMITED·05060528013529·P-P02 - PERFORATOR HANDPIECE - AIR

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964084553·Endo Carry-On Procedure Kit

Sochi

FDA UDI
Altus Spine, LLC·00843210166285·Standard Screw,3.5mm x 24mm

Cortium Universal OCT Spinal Fixation System

FDA UDI
Ulrich Medical Usa, Inc.·00814386026406·Screw, Ø 3.5mm, length 24mm, high angulation

Atoll™

FDA UDI
Seaspine Orthopedics Corporation·10889981052171·3.5mm x 24mm Standard Screw. The Atoll OCT Spin...

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 15, 2019

POLYTEL(R) APT MODEL: PWA-08-01

FDA 510(k)
FDA Class 2 ·Cardiovascular

TROCHANTERIC DYAX NAIL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Gibralt

FDA UDI
Choice Spine, LP·10885862303042·

Gibralt®

FDA UDI
INNO Holdings, Inc.·M711050021035240·POSTERIOR CERVICAL, ROD, STRAIGHT, CoCr, 3.5 X ...

GALAXY G3 MINI 2MM X 4CM

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·March 16, 2021

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTN·May 9, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

INFUSO.R.

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 26, 2011

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

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021