19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RFS VACUUM GAUGE SCAVENGING CIRCUIT
FDA 510(k)
FDA Class 2
·Anesthesiology
PowerMix™ Cartridge Connectors
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883002619·120 mL cartridge connector adapter
PowerMix™ Cartridge Connectors
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172016780·120 mL cartridge connector adapter
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033503·Baltic Denture System BDLoad BDLoad ↓ Sm6 PLSEu...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0315030·Probe, 1.5 inch Ball, Steffee, Curved, Impaction
MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
N LATEX CYSTATIN C
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PINN SECTOR W/GRIPTION 52MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·April 3, 2013
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIV.·Product code LGW·March 24, 2011
LOGICAL 60" SINGLE LINE MONITORING KIT
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD·Product code DRS·April 2, 2008
PROGREAT
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQO·March 5, 2024
BLOOD GROUPING REAGENTS ANTI-A (MURINE MONOCLONAL BLEND) BIOCLONE
FDA Adverse Event
Malfunction
·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·July 29, 2018
BLOOD GROUPING REAGENTS ANTI-A (MURINE MONOCLONAL BLEND) BIOCLONE
FDA Adverse Event
Malfunction
·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·July 29, 2018
TERUMO PROGREAT CATHETER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQO·February 6, 2023
PROGREAT CATHETER
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQO·January 6, 2024
PROGREAT
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQO·April 15, 2025
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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013