11 results
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18ms
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Sources: EU EUDAMED, US FDA
FLORA-STAT URINE TRANSPORT SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113509·MINIATURE BLADE #67 (BX/5)
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112361·3M™ Victory Series™ First Molar Bands, 902-467,...
COALIZA PROTEIN S-FREE
FDA 510(k)
FDA Class 2
·Hematology
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED
FDA 510(k)
FDA Class 2
·Neurology
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 19, 2020
ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code BTR·May 7, 2014
DUROM US ACETABAR COMPONENT 48/42 H
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·November 10, 2010
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·January 8, 2013
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