11 results
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19ms
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Sources: EU EUDAMED, US FDA
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ADVANT 80X200 2022-561 MUESTRA
Device
EU MDR
·
Eu Md Class 1
·INDUSTRIAS HIDRÁULICAS PARDO SL·On the market
ADVANT 83X200 2022-561 MUESTRA
Device
EU MDR
·
Eu Md Class 1
·INDUSTRIAS HIDRÁULICAS PARDO SL·On the market
SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT
FDA 510(k)
FDA Class 2
·Immunology
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
2.4MM TI HDLSS COMPRESSION SCR 10MM/SHORT THREAD-STERILE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·November 3, 2023
SJM EPIC STENTED PORCINE HEART VALVE
FDA Adverse Event
Death
·ST. JUDE MEDICAL COSTA RICA LTDA. (CS)·Product code LWR·March 22, 2013
COMPACT EXCHANGE DEVICE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - LARGO·Product code KDJ·March 17, 2011
V-CATH NEO MAGIC
FDA Adverse Event
Other
·HDC CORP.·Product code LJS·March 31, 2008
Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengths in 4 mm increments. They are 30 mm, 34 mm, 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 127, 130 and 132. The versions are 0, 8, 16 degrees. In total there are 16 unique neck implants in the Rejuvenate Modular System.
FDA Enforcement
Class II
·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012
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