13 results
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28ms
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Sources: EU EUDAMED, US FDA
URINE COOLECTION BAG TYPE 2090V
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5828027360·ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
neria™
FDA UDI
Unomedical A/S·05705244000551·Single use infusion set for subcutaneous infusi...
thalaset™
FDA UDI
Unomedical A/S·05705244001251·Single use infusion set for subcutaneous infusi...
RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PRE-DENT SYSTEM
FDA 510(k)
FDA Class 1
·Hematology
DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXB·February 14, 2020
RADIFOCUS OPTITORQUE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·May 9, 2014
SYNERGY
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 24, 2012
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 17, 2010
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