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