13 results
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19ms
·
Sources: EU EUDAMED, US FDA
BODYHEAT
FDA 510(k)
FDA Class 2
·Cardiovascular
Bioseal Inc.
FDA UDI
BIOSEAL·00630094190266·Latex Dental Rubber Bands
NA
FDA UDI
Zimmer, Inc.·00889024365339·
NA
FDA UDI
Zimmer, Inc.·00889024365346·
VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEARTWAY POWER MOBILITY SCOOTER, S12
FDA 510(k)
FDA Class 2
·Physical Medicine
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 30, 2014
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 18, 2010
MAK OSS RS SEGMENTAL ELLIPTICAL FEMORAL COMPONENT 7CM RIGHT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·May 28, 2025
ORTHOPEDIC SALVAGE SYSTEM IM STEM WITH SCREW 11MM X 150MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 28, 2025
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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