16 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040013243·Zirlux 16+ B2 98.5X12
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964153112·Endo Carry-on Procedure Kit contains Revital-Ox...
STILLE Scissors
FDA UDI
Stille AB·07332339102708·METZENBAUM STILLE SUPERCUT ERGO SCISSORS curved...
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST
FDA 510(k)
FDA Unclassified
·Unknown
GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENDOCARE, CRYOCARE, CRYOPROBE
FDA Adverse Event
Malfunction
·HEALTHTRONICS, INC.·Product code GEH·April 2, 2012
VERTEBRAL SPACER-TR 10MMX27MM 11MM HEIGHT
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code MQP·February 20, 2013
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 8, 2011
PASSIVE PLUS
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008
MINIMED SURE-T
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 22, 2025
ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 7, 2016
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
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024