17 results
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24ms
·
Sources: EU EUDAMED, US FDA
XTRACT CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
KEY SURGICAL, INC.·10849771049798·Steinmann Pins, Single trocar, round end, 0.188...
ConMed Linvatec
FDA UDI
Provision·B504OM50715290·
HALL
FDA UDI
Conmed Corporation·10845854009482·LARGE BONE, HALL BLADE, OSCILLATING, 19.5 X 105...
T2 HUMERAL NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA
FDA 510(k)
FDA Class 1
·General Hospital
S-ROM*SLEEVE PRX ZTT, 16D-LRG
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·December 12, 2013
PINNACLE 100 ACET CUP 54MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·December 12, 2013
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·December 12, 2013
S-ROM*STM STD,36NK,16X11X150
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 12, 2013
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·December 12, 2013
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
EXPEDIUM DI FINAL TIGHTENER
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code HWR·April 22, 2013
TAPERED SPACER ARTICUL/EZE -3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LZY·April 15, 2011
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC.·Product code NBW·July 3, 2008
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 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