14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZURICH DISTRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101090·Distractor, Smooth Paddle, Lordotic, 9mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101090·Distractor, Smooth Paddle, 9mm
PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
FDA 510(k)
FDA Class 2
·Cardiovascular
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
MINIMED MIO ADVANCE
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·May 20, 2025
ONE TOUCH PING METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·June 3, 2010
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWA·March 19, 2013
MP50 INTELLIVUE PATIENT MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·February 11, 2011
NA
FDA Adverse Event
Other
·B. BRAUN MEDICAL INC·Product code FMI·March 10, 2008
COBAS C111
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·March 3, 2010
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013
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