20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Safco D1amond
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063751866·Sterile Single Use Burs - ISO Code 863-014F
ANODYNE Plate System
FDA UDI
CORELINK LLC·M7252024015·ANODYNE CERVICAL SCREW - VARIABLE SELF TAPPING...
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193107233·HA PEEK EVOS Straight, ,15mmx10mmx 22mm , BICON...
Secure-Loop 15 mm
FDA UDI
XIROS LTD·05060267131423·
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710310240150·Talar Osteotmy Guide, 24mm x 15mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710810240150·Dwyer Calcaneal Guide, 24mm x 15mm
OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BEAM BLOCK TRAYS
FDA 510(k)
FDA Class 2
·Radiology
INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code MHY·March 10, 2022
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·March 7, 2019
INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code MHY·May 17, 2024
ENTERRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LNQ·March 27, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 14, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP.
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 5, 2008
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·July 23, 2025
PROCLAIM 7 ELITE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·September 13, 2018
PANEL PHOENIX NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 22, 2023
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018