15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPINAL CONCEPTS INC. CADENCE AND TRAXIS
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033517·Baltic Denture System BDLoad BDLoad ↓ Mn7 PLSEu...
BD MAX¿ EXK¿ TNA-3
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JJH·January 28, 2022
Implant-One
FDA UDI
Implant Logistics, Inc.·D762MUA0335170·300 Series Multi-Unit Abutment, 17 Degree Angle...
Implant-One
FDA UDI
Implant Logistics, Inc.·D762DEN0335170·300 Series Denture Retaining Abutment, 17 Degre...
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·April 15, 2021
10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600
FDA 510(k)
FDA Class 2
·Cardiovascular
OTRES TOOTHBRUSH SANITIZER MODEL TB100W
FDA 510(k)
FDA Class 1
·Dental
ACQSIM CT SCANNER
FDA Adverse Event
Malfunction
·PHILIPS·Product code JAK·August 12, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - BUFFALO GROVE·Product code FRN·April 3, 2013
QUATTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 24, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 23, 2008
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·April 29, 2020
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024