10 results
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18ms
·
Sources: EU EUDAMED, US FDA
CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS
FDA 510(k)
FDA Class 2
·Cardiovascular
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113523·SLIT BLADE 3.0MM STR (BX/5)
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112446·3M™ Victory Series™ First Molar Bands, 902-475,...
PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G
FDA 510(k)
FDA Class 2
·Orthopedic
REPLACE TPS COATED IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 30, 2014
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
GOODBABY·Product code INM·January 8, 2013
ST104 TRANSPORT
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIVISION·Product code FPO·November 12, 2010
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