19 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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QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OIC Sliding Hip Screw (SHS) System
FDA UDI
ORTHOPAEDIC IMPLANT COMPANY, THE·M696SHS1300780·SLIDING HIP SCREW PLATE, 130 DEGREE, 4 HOLE, ST...
OIC Sliding Hip Screw (SHS) System
FDA UDI
ORTHOPAEDIC IMPLANT COMPANY, THE·10811998032457·SLIDING HIP SCREW PLATE, 130 DEGREE, 4 HOLE, ST...
TISSUE FORCEPS CUSHING - 7"-SERRATED-CURVED
FDA UDI
W.H. Holden, Inc.·D9281300780·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450188019·
BURBANK TENACULUM, MODEL 09-0011-01
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODIFIED STRAIGHT FIRE LASER FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DORMA 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 16, 2022
Widex
FDA UDI
Widex A/S·05706069884418·WIDEX MOMENT MRR2D (Mediterranean turquise ) 33...
Widex
FDA UDI
Widex A/S·05706069671650·Widex EVOKE E-FA (Mediterranean turquise ) 330,...
Widex
FDA UDI
Widex A/S·05706069972122·WIDEX MOMENT MBB2 330 (Mediterranean turquoise)
Widex
FDA UDI
Widex A/S·05706069553734·Widex UNIQUE U-FA (Mediterranean turquise ) 330...
Widex
FDA UDI
Widex A/S·05706069556421·Widex D-FA P (Mediterranean turquise ) Dream 33...
Widex
FDA UDI
Widex A/S·05706069923322·WIDEX MOMENT MBB3D 330 (Mediterranean turquoise)
SCORPIO SIZE 5 CR INSERT 8MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 24, 2013
PARADIGM REAL-TIME REVEL INSULIN INFSUIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 18, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 16, 2011
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015