20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS
FDA 510(k)
FDA Class 2
·Dental
SOAR Retractor System
FDA UDI
SPINEOLOGY INC.·M7403031807·18MM X 70MM Tube
Reusable Bladderless Cuffs Starter Kit
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904089478·
TISSUE MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCS CLARIS SPINAL SCREWS, TYPES V,G,E
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 12, 2026
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 2, 2013
MX-PRO R-3 AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·February 25, 2011
LEAVE ACTIVE PFC CVD 10MM SZ4
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 17, 2008
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
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
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 6, 2015