15 results
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20ms
·
Sources: EU EUDAMED, US FDA
ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215022396·
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00190376074269·Polyaxial Screw, 7.2 mm x 125 mm
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00844856085725·SACRAL POLYAXIAL SCREW, 7.2mm X 125mm
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00190376078069·Polyaxial Reduction Screw, 7.2 mm x 125 mm
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00844856084575·POLYAXIAL SCREW, 7.2mm X 125mm
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00844856086906·POLYAXIAL REDUCTION SCREW, 7.2mm X 125mm
PINS AND WIRES
FDA 510(k)
FDA Class 2
·Orthopedic
OPUS MAGNUM ANCHOR & INSERTER
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 13, 2024
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
CAPSURE EPI
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·July 10, 2008
3 LEAD EXTENSION SET W/0.22 MICRON AIR ELIMINATING
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·April 28, 2011
ENTERPRISE2 4MMX23MM
FDA Adverse Event
Injury
·CODMAN AND SHURTLEFF, INC·Product code NJE·August 8, 2018
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