11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MONARCH SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ES™ TROCHANTERIC NAIL, RIGHT, Ø10mm x 33cm x 125°
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665022148·
ULTRAPOWER
FDA UDI
Conmed Corporation·10845854006696·ULTRAPOWER BUR, ROUND/CYLINDRICAL (LIME), 1.8 MM
SYNTHS ONE-THIRD TUBULAR DCL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED
FDA 510(k)
FDA Class 2
·Orthopedic
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·March 26, 2013
MESH - COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·March 8, 2011
ICY HOT HEAT THERAPY PATCH
FDA Adverse Event
Other
·CHATTEM, INC.·Product code IMD·March 27, 2008
NGAGE NITINOL STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code FFL·July 24, 2018
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 Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014