18 results · 27ms · Sources: EU EUDAMED, US FDA

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VARIOSURG

FDA 510(k)
FDA Class 2 ·Dental

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code DZI·October 6, 2020

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code DZI·July 15, 2025

NSK

FDA Adverse Event
Malfunction ·NAKANISHI INC.·Product code ELC·September 9, 2016

VICTORCH MEDITEK'S HCG TEST CARD

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMISIL SCAR GEL

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

SPECTRANETICS QUICK-CROSS SUPPORT CATHETER

FDA Adverse Event
Injury ·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019

HOMECHOICE

FDA Adverse Event
Death ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 23, 2013

ACCENT DR RF

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·September 9, 2014

COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

FDA Adverse Event
Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·April 13, 2011

PINNACLE MTL INS NEUT36IDX54OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 22, 2013

ARTICULEZE M HEAD 36MM +1.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 22, 2013

ARTICULEZE M HEAD 36MM +1.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·March 15, 2010

PINNACLE MTL INS NEUT36IDX52OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·March 15, 2010

PRODIGY LG STAT SHT RT 12.0MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·March 15, 2010

PINNACLE 300 ACET CUP 52MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·March 15, 2010

REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.

FDA Enforcement
Class II ·Ongoing·ICU Medical, Inc.·May 19, 2021

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