11 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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NA LATEX MYOGLOBIN TEST
FDA 510(k)
FDA Class 2
·Immunology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112892·CORNEAL TREPHINE BLADE7.0MM
Elite®
FDA UDI
Ortho Organizers, Inc.·00190707051952·.022 L6L DBT/NC 0T 5 OFF
HEARTWAY POWER MOBILITY SCOOTER, S9
FDA 510(k)
FDA Class 2
·Physical Medicine
K.E.A.T.
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 30, 2014
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·January 8, 2013
PFC SIG CR NPOR FEM LT SZ 4N
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·November 15, 2010
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·May 25, 2021
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
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020