13 results
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21ms
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Sources: EU EUDAMED, US FDA
CONTOUR SE MICROSPHERES
FDA 510(k)
FDA Class 2
·Cardiovascular
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091034068·Baltic Denture System BD Load BDLoad Ln6 PLSEb...
SlimLine®
FDA UDI
ZIMMER SPINE, INC.·00889024403741·
E-Z Tie Tubing
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746170720·ELASTOMERIC EZ-TIE TUBING .025 TRANSPARENT 25'
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
FDA 510(k)
FDA Class 1
·Dental
ACURA ELITE GRAVITY COMPENSATING RESERVOIR
FDA 510(k)
FDA Class 2
·Neurology
SYNCHRON® CK 2 X 400
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CKA·May 10, 2011
PRECISION SPECTRA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 15, 2024
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·April 3, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 24, 2011
4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code GEI·April 24, 2008
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
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024