16 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 3, 2020
MINIMED MIO ADVANCE
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 2, 2025
MINIMED MIO ADVANCE
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·August 1, 2025
REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830
FDA 510(k)
FDA Class 2
·Anesthesiology
7-DAY LL VLV ADPT(STAND ALONE)
FDA Adverse Event
Malfunction
·ISIA D.O.O. CAZIN·Product code FPA·June 11, 2020
7-DAY LL VLV ADPT(STAND ALONE)
FDA Adverse Event
Malfunction
·ISIA D.O.O. CAZIN·Product code FPA·June 11, 2020
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code LXH·March 31, 2017
X SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 22, 2013
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·March 2, 2011
CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·March 12, 2008
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code NKB·December 29, 2024
7-DAY LL VLV ADPT(STAND ALONE)
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·June 24, 2020
The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm TRL092002508 Humeral Stem Trial, 8mm TRL092002509 Humeral Stem Trial, 9mm TRL092002510 Humeral Stem Trial, 10mm TRL092002511 Humeral Stem Trial, 11mm TRL092002512 Humeral Stem Trial, 12mm TRL092002513 Humeral Stem Trial, 13mm TRL092002514 Humeral Stem Trial, 14mm TRL092002515 Humeral Stem Trial, 15mm TRL092002516 Humeral Stem Trial, 16mm
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·May 2, 2018
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