15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE
FDA 510(k)
FDA Class 2
·Immunology
VARIAX
FDA UDI
Stryker GmbH·07613154976331·Metal Insert Elbow System for Instruments
DISTRACTION, INTERNAL
FDA UDI
KLS-Martin L.P.·00888118092922·DIST, ALVEOLAR, TRACK 2.0, COLOGNE GORDON, END ...
DISTRACTION, INTERNAL
FDA UDI
KLS-Martin L.P.·00888118092939·DIST, ALVEOLAR, TRACK 2.0, COLOGNE GORDON, END ...
PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETA·February 19, 2016
TITAN PLUG SCREW 8MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA GMBH·Product code HSB·February 21, 2002
TITANIUM MIDDLE EAR PROSTHESES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LAP LOOP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·May 7, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·October 12, 2022
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 30, 2014
ADJ WIRE COLLET 0.7-1.8MM
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·November 12, 2010
S-ROM M HEAD 36MM +3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·January 9, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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