20 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
infinity OCTAGON BL RC Healing abutment, conical Ø 5.0mm GH 4.0 mm
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50220911·BL RC Healing abutment, conical Ø 5.0mm GH 4.0 ...
16PW - Class A 21 Kent - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588620916·16PW - Class A 21 Kent - Poly White
BD FEMALE LL ADAPTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·December 16, 2024
BD FEMALE LL ADAPTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·December 16, 2024
BD FEMALE LL ADAPTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·December 16, 2024
BD FEMALE LL ADAPTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·December 16, 2024
PRO-FEMUR
FDA 510(k)
FDA Class 2
·Orthopedic
OPTILUX 501
FDA 510(k)
FDA Class 2
·Dental
FEMALE LL ADAPTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·July 8, 2021
BD FEMALE ADAPTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·May 29, 2025
OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 3
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 29, 2023
TENOR SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·December 27, 2010
V 2.0 SOFT EXT PTFE
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·March 26, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·February 28, 2011
VIABAHN ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES, INC.·Product code NIP·March 27, 2008
TENOR SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·December 27, 2010
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·April 12, 2022
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