12 results
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19ms
·
Sources: EU EUDAMED, US FDA
CALCIUM:ARSENAZO III
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113530·SLIT BLADE 3.0MM ANGLED (BX/5)
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112453·3M™ Victory Series™ First Molar Bands, 902-476,...
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 2, 2019
LUMBOPERITONEAL SHUNT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M
FDA 510(k)
FDA Class 2
·Physical Medicine
ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code BTR·May 7, 2014
BECKMAN COULTER AU600 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMA K.K.·Product code JJE·January 8, 2013
HIRES 90K
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·November 11, 2010
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·November 11, 2024
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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