47 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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U-Motion II Acetabular System Additional sizes
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHES T-PAL SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTERMED LIVE
FDA 510(k)
FDA Class 2
·Radiology
ACCESS® VITAMIN B12
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code CDD·January 31, 2012
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 14, 2013
ACRYSOF TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD/ HUNTINGTON·Product code HQL·June 17, 2011
MINILINK TRANSMITTER
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·October 14, 2014
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·December 13, 2021
REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·July 5, 2023
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·November 24, 2022
Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369 71156 71551-02 71413 71692 74102 75490 74432-01 75477 75478 75104-02 75104-03 75477-01 75037 75973 75308-01 75688 70571-06 75114-01 72755 73306 71180-01 73307 75163 75164 75787 75163-01 73055-02 75450 75451 75452 75453 75453-01 75999 75451-01 72481-01 75197 73968 75416 73648 71519-02 71801-01 72846 74163-02 74178-03 74986 75607 74162-01 74163-03 73454-01 71296-01 74924 73344-04 73500-04 74924-01 73143-02 76393 74248-01 73820-01 75261 75594 74022-01 66001-01 66004-01 74916 72736-02 B72736-02 70815 70815-01 70815-02 74356-02 73208-03 73001-02 73957-01 74460-01 70089-06 75168 75171 75240 74382-01 66467 70089-07 74965-03 75168-01 75240-01 66467-01 70089-08 73177 76006 73177-01 76038 75252-01 76316 75805-02 73346 76414 75790 75678 62007-01 66229 75075 62007-02 65382 75788 75788-01 70533-10 75936 75936-01 63123 72241 70148-02 70730 70772 74732 75090 75090-01 75090-02 75089-01 73468 74430 74921-02 75881 64523-02 64619-02 64522-03 64521-02 65560-03 64912-04 65560-04 71064 65570 71062-01 71061-02 71060-01 71962-04 71965-04 75948 71962-05 74401-01 74400-01 74399-02 75944 759
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTL·June 27, 2017
Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017
SHOULDER SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PHX·December 2, 2024
ANATOMIC SHOULDER PROSTHESIS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWS·May 23, 2025
REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·January 12, 2022
REVERSE SHOULDER SYSTEM GLENOSPHERE 36X27
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·June 25, 2021
ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWS·September 21, 2021
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·November 24, 2022
SHOULDER SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PHX·November 13, 2024
SHOULDER SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PHX·November 18, 2024