11 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032348·Baltic Denture System BDLoad Sw7 PLSEbm6DFs A3,...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120323481·Diamond, torpedo, COOL DIAMANT, coarse grit, gr...
ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000
FDA 510(k)
FDA Class 2
·Anesthesiology
MAXIM RPG PS FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·March 29, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 22, 2011
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·April 22, 2008
ACCUVUE ADVANCE
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·October 19, 2007
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
I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026