13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENTACT SEPTAL STAPLER, MODEL 610-00100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Centaur Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215127107·
HL168T
FDA 510(k)
FDA Class 2
·Cardiovascular
ADC PEDIATRIC
FDA 510(k)
FDA Class 2
·Radiology
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·June 10, 2025
WALLFLEX DUODENAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MUM·January 22, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013
MP30 INTELLIVUE PATIENT MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·April 28, 2011
AFFINITY BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code HDD·July 23, 2008
MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 9, 2025
Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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