15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033447·Baltic Denture System BDLoad BDLoad ↓ Lm6 PLSEu...
ISOBAR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROTRACT PRESS FIT HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
CROSS PLATE MTP, RIGHT ANCHORAGE
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HRS·November 27, 2024
VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER
FDA Adverse Event
Injury
·DIGITAL ANGEL CORPORATION/ JAMM TECHNOLOGIES·Product code NRV·August 5, 2022
REACH BY DESIGN TOOTHBRUSH/ULTRACLEAN
FDA Adverse Event
Malfunction
·SKILLMAN CONTRACT·Product code EFW·April 3, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 23, 2011
ALLEGIANCE TRANSPARENT DRESSING
FDA Adverse Event
Malfunction
·ASPEN SURGICAL PRODUCTS, INC.·Product code NAD·April 22, 2008
CROSS PLATE MTP, RIGHT ANCHORAGE
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HRS·November 25, 2024
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
RUNWAY GUIDE CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013
CROSS PLATE MTP, RIGHT ANCHORAGE
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HRS·November 21, 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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024