21 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INFINTT CO., LTD. STARPACS SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Cetro America Ultrasound Transducer for HP8040
FDA UDI
CETRO AMERICA INC·00852519007038·Replacement ultrasound transducer for HP8040 mo...
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193107752·HA PEEK EVOS Straight, ,13mmx11mmx 30mm , FLAT ...
Medial Pilon Plate, Left, Short, 13-Hole
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665024630·
Intelliguides
FDA UDI
Mios Marketing, LLC·G2711020310130·Lateral Midfoot Charcot Guide, 31mm x 13mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710620310130·Quad Channel Met-Traverse, 31mm x 13mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710810310130·Dwyer Calcaneal Guide, 31mm x 13mm
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
FDA 510(k)
FDA Class 2
·Neurology
MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.
FDA 510(k)
FDA Class 2
·Cardiovascular
SPINEMED TABLE - FDA 510(K) K051013
FDA Adverse Event
Other
·CERT HEALTH SCIENCES, LLC·Product code ITH·July 16, 2007
COLLAGEN TAPE - HELITAPE 1 X 3 (2.5CM X 7.5CM)
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC.·Product code EKR·March 28, 2013
ANKYLOS C/X IMPLANT
FDA Adverse Event
Injury
·FRIADENT GMBH·Product code DZE·March 16, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008
LGC TIBIAL FIT TRAY CEM SZ 3F / 3T
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 29, 2025
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 18, 2025
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
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 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