19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERSA-LOCK(TM) UNIVERSAL NEEDLE CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
N/A
FDA UDI
Smith & Nephew, Inc.·00885556601839·SOD DILATOR W/T-HANDLE 6.00MM
Triton
FDA UDI
ASI MEDICAL, INC.·00850309007060·Triton Assistant’s System
Elite® Bondable Buccal Tubes
FDA UDI
Ortho Organizers, Inc.·00190707070755·Elite®.018 L6L STD -12T DB
TCP
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420118745·
NexGen®
FDA UDI
Zimmer, Inc.·00889024201767·
STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
FDA 510(k)
FDA Class 2
·Orthopedic
ELECTRONIC GAS BLENDER
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·November 19, 2025
STOCKERT S3 GAS BLENDER
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·December 22, 2014
3.5MM VA-LCP PROX TIBIA PLATE LARGE BEND/12H/207MM/RT-STER
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HRS·January 8, 2013
ALARIS PUMP MODULE 8100
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FRN·October 19, 2010
QUADRA ASSURA MP CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 30, 2014
S3 GAS BLENDER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017
S3 GAS BLENDER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017
S3 ELECTRONIC GAS BLENDER
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·December 19, 2024
SORIN S3 GAS BLENDER
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTX·February 25, 2015
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·April 8, 2024
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