11 results
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24ms
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Sources: EU EUDAMED, US FDA
SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID
FDA 510(k)
FDA Class 2
·Microbiology
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984144·anteriors; shade A3.5; mould R 60
P.F.C.
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295252344·P.F.C. TIBIAL INSERT FIXED BEARING CURVED 2 12....
TURBOX ANTITHROMBIN III
FDA 510(k)
FDA Class 2
·Hematology
POWER EXAMINATION TABLE MODEL # 405
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·February 28, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 10, 2011
SUPER SUCKER SHORT CURVED (BX/20)
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code KDC·December 18, 2013
Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 12.5 mm; Ref 98-4144.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code JWH·May 26, 2005
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24, 13) REF 21-7359-24, 14) REF 21-7383-24, 15) REF 21-7390-24, 16) REF 21-7391-24, 17) REF 21-7394-24, 18) REF 21-7395-24, 19) REF 21-7301-24JP, 20) REF 21-7302-24JP, 21) REF 21-7321-24JP, 22) REF 21-7322-24JP, 23) REF 21-7359-24JP, 24) REF 21-7394-24JP
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·February 8, 2023
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24, 13) REF 21-7349-24, 14) REF 21-7359-24, 15) REF 21-7363-24, 16) REF 21-7383-24, 17) REF 21-7391-24, 18) REF 21-7394-24, 19) REF 21-7600-24, 20) REF 21-7609-24, 21) REF 21-7624-24, 22) REF 21-7649-24, 23) REF 21-7301-24JP, 24) REF 21-7302-24JP, 25) REF 21-7308-24JP, 26) REF 21-7309-24JP, 27) REF 21-7322-24JP, 28) REF 21-7359-24JP, 29) REF 21-7394-24JP, 30) REF 21-7600-24JP, 31) REF 21-7609-24JP, 32) REF 21-7624-24JP, 33) REF 21-7649-24JP. Computerized Ambulatory Delivery Device
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·February 8, 2023