14 results
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19ms
·
Sources: EU EUDAMED, US FDA
BK-1499 KAY-KPLINT HAND CONE/BK-1500
FDA 510(k)
FDA Class 1
·Physical Medicine
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750006717·VITROS Chemistry Products Calibrator Kit 23
N/A
FDA UDI
GEORGE TIEMANN & CO.·B58208017070·RETRACTOR, ALL TYPES
Phantom Tibial Preparation
FDA UDI
ADLER ORTHO SPA·08056269043717·GENUS PANTHEON PHANTOM TIBIAL PREPARATION SZ.7
ESTEEM PLUS ONE-PIECE DRAINABLE POUCH
FDA Adverse Event
Malfunction
·CONVATEC, PURCHASING DEPARTMENT·Product code EZQ·April 11, 2019
DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
ESTEEM
FDA Adverse Event
Malfunction
·CONVATEC·Product code EZQ·August 5, 2019
CODMAN LUMBAR CATHETER KIT
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF·Product code JXG·June 12, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 9, 2014
10MM POSTERIOR FEMORAL AUGMENT, SIZE: F
FDA Adverse Event
Injury
·ZIMMER TMT·Product code JWH·October 12, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·September 27, 2007
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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