14 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AVS PL PEEK SPACERS
FDA 510(k)
FDA Class 2
·Orthopedic
LEONE SPA
FDA UDI
LEONE SPA·08033707065692·INTRAORAL ELASTICS 4,5 oz 3/16" green
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 25, 2023
OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDIPLUS SINGLE USE GI MANOMETRY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·May 6, 2013
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code FSA·September 16, 2014
S-ROM*STM STD,36NK,14X09X130
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 12, 2011
DXTEND SCREW NO LOCK D4.5X18MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code HSD·April 29, 2026
DXTEND SCREW NO LOCK D4.5X18MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code HSD·April 29, 2026
DXTEND SCREW LOCK D4.5X24MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code HSD·April 29, 2026
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems.
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code LNH·May 6, 2004
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