21 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COLLATEK POWDER
FDA 510(k)
FDA Unclassified
·Unknown
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·December 18, 2025
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00031568448348·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00031568448331·
A NEW DAY
FDA UDI
FGX INTERNATIONAL INC.·00193033449899·
A NEW DAY
FDA UDI
FGX INTERNATIONAL INC.·00195994474613·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00031568448294·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00031568448270·
VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001
FDA 510(k)
FDA Class 2
·Neurology
AMS SLING FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 26, 2025
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·March 20, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code LWS·March 10, 2011
CERAMTEC CERAMIC INS/SLEEVE TRIDENT G
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS CORK·Product code MRA·January 9, 2008
Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012
Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012
Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012
Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012
Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
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