17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DBX DEMINERALIZED BONE MATRIX PUTTY
FDA 510(k)
FDA Class 2
·Orthopedic
ConMed Linvatec
FDA UDI
Provision·B504OM50912180·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450259832·
CONMED
FDA UDI
Conmed Corporation·10845854003152·SIDECUTTING BUR, MEDIUM, TAPERED, 1.6 X 4.5 MM
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
FDA 510(k)
FDA Class 2
·Orthopedic
CORRECT PLUS
FDA 510(k)
FDA Class 2
·Dental
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·November 7, 1997
CLINITEK STATUS+
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JHI·December 2, 2019
ADULT BREATHING CIRCUIT
FDA Adverse Event
Other
·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·June 21, 2010
ADULT BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·October 28, 2010
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·October 16, 2020
PANORAMA CENTRAL STATION W/ TELEPACK
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014
I-STAT G3+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE CANADA LTD.·Product code JGS·April 20, 2011
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
FDA Enforcement
Class II
·Ongoing·Lacrimedics Inc·March 9, 2022
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 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