15 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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UNIVERSAL TOTAL WRIST SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Humelock Reversed Shoulder
FDA UDI
FX SOLUTIONS·03701037306048·EXTENSION
Discectomy Set
FDA UDI
SPINEOLOGY INC.·M7403030037·Right Facing 30 degree Serrated Curette
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·RITHRON-XR CORONARY STENT SYSTEM
Scissors, Micro, acc. Potts round-handle 17cm 90° edge 10mm
FDA UDI
Geister Medizintechnik GmbH·04057034003770·Scissors, Micro, acc. Potts
round-...
JEWEL CAST III
FDA 510(k)
FDA Class 2
·Dental
MONOFILAMENT BIOSYN SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·February 24, 2017
ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK INC·Product code NIO·July 25, 2017
7.0MM TI SIDE-OPENING SCREW 55MM
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MNH·April 2, 2013
TECNIS MULTIFOCAL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·March 25, 2011
PUMP MMT-722CAL PRDGM INS V2.2 CL EN PR
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·April 14, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - 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
BACFIX ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020
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