14 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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Parcus Titanium Interference Screws
FDA 510(k)
FDA Class 2
·Orthopedic
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112557·BARRON VACUUM TREPHINE 9.0MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112977·CORNEAL TREPHINE BLADE9.0MM
Sklar®
FDA UDI
SKLAR CORPORATION·10649111169588·GILLIES NH 6" SERR
DIATEK CANNON-CATHETER, MODEL CC5500
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HARDYDISK CLINDAMYCIN, 2MCG
FDA 510(k)
FDA Class 2
·Microbiology
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 27, 2014
DISPOSABLE SUTURE PLACEMENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code GCJ·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 16, 2024
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code HRH·May 3, 2013
TRICLIP DELIVERY SYSTEM (TCDS)
FDA Adverse Event
Death
·ABBOTT MEDICAL·Product code NPS·April 30, 2026
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