12 results
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19ms
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Sources: EU EUDAMED, US FDA
EURAMARK 610 PHOTOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113981·HYDRO-DISSECT CANNULA 27GA ANGLED 8MM
3.25 SPLINE TWIST IMPLANT, HA COATED
FDA 510(k)
FDA Class 2
·Dental
TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD Ø46
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWS·April 12, 2023
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 29, 2016
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 30, 2014
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 2, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWY·November 12, 2010
ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD Ø46
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWS·October 4, 2023
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 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