22 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
FDA 510(k)
FDA Class 2
·Anesthesiology
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964070013·The ENDO CARRY-ON Procedure Kit contains all of...
FUSION MEDICAL RING LOCK SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Widex
FDA UDI
Widex A/S·05706069727036·Widex EVOKE E-PA (Tech Black S-440 ) RC coil
UNKNOWN BIOMET SHELL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·March 6, 2024
VIVACIT-E DM BEARING 28X38MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·March 22, 2024
BIOLOX DELTA CER OPTION HD 28MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·March 25, 2024
2520274-2013-02476
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·May 9, 2013
11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·September 19, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 25, 2011
11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·February 11, 2016
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 L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Model Number L210 PROPONENT SR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
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
Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021