23 results
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21ms
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Sources: EU EUDAMED, US FDA
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
FDA 510(k)
FDA Class 2
·Hematology
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00141451·
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964011069·Endo Carry-On Procedure Kit includes Intercept ...
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001145·artVeneer life upper anteriors, IXL, A4
OsteoMed
FDA UDI
OSTEOMED LLC·00845694031219·PrimaLOK FF 45mm Implant Assembly
primaLOK FF
FDA UDI
Wenzel Spine, Inc.·00813210021990·primaLOK FF 45mm Implant Assembly, Sterile ...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694031875·PrimaLOK FF 45mm Implant Assembly, Sterile
OsteoMed
FDA UDI
OSTEOMED LLC·00845694031929·PrimaLOK FF 45mm Implant Assembly, 2 Pack, Sterile
MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS
FDA 510(k)
FDA Class 2
·Orthopedic
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
2001145-MMJB STIM MODULE CABLE
FDA Adverse Event
Malfunction
·C.R. BARD, INC.·Product code DRQ·May 12, 2004
REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +9MM/0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 19, 2021
BD MALE LL ADAPTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·July 17, 2024
PROTECTOR P50 MULTIPACK
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·August 29, 2020
TECNIS EYHANCE IOL WITH TECNIS SIMPLICITYTM DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·May 6, 2025
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013
THE KOH COLPOTOMIZER SYSTEM
FDA Adverse Event
Malfunction
·COOPERSURGICAL - THE KOH COLPOTOMIZER SYSTEM·Product code HEW·February 7, 2011
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·February 15, 2008
Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·November 21, 2012
Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 138919-01 138920-01 138921-01 138922-01 138923-01 138924-01 138926-01 138927-01 138928-01 138929-01 138930-01 138931-01 138932-01 138933-01 138934-01 138936-01 138937-01 138938-01 138939-01 138940-01 138941-01 138942-01 138943-01 138944-01 138945-01 138946-01 138947-01 138948-01 138949-01 138950-01 138951-01 138952-01 138953-01 138954-01 138955-01 138956-01 138957-01 138958-01 138959-01 138960-01 138961-01 138962-01 138963-01 138964-01 138965-01 138966-01 138967-01 138968-01 138969-01 138970-01 138971-01 138972-01 138973-01 138974-01 138975-01 138976-01 138977-01 138978-01 138989-01 138990-01 139000-01 139001-01 139002-01 139011-01 139013-01 139016-01 139018-01 139019-01 139020-01 139021-01 139022-01 139023-01 139028-01 139062-01 139063-01 139073-01 139082-01 139084-01 139085-01 139086-01 139091-01 139122-01 139125-01 139126-01 139127-01 139128-01 139131-01 139141-01 139142-01 139156-01 139163-01 139170-01 139171-01 139172-01 139174-01 139175-01 155081-01 155082-01 155083-01 155084-01 155085-01 155086-01 155087-01 155088-01 155089-01 155090-01 155091-01 155092-01 155093-01 155094-01 155095-01 155096-01 155097-01 155098-01 155099-01 155100-01 155101-01 155102-01 155103-01 155104-01 155105-01 155106-01 155107-01 155108-01 155109-01 155110-01 155111-01 155112-01 155113-01 155114-01 155115-01 155116-01 155117-01 155118-01 155119-01 155120-01 155121-01 155122-01 155123-01 155124-01 155125-01 155126-01 155127-01 155128-01 155129-01 155130-01 155131-01 155132-01 155133-01 155134-01 155135-01 155136-01 155137-01 155138-01 155139-01 155140-01 155141-01 155142-01 155143-01 155144-01 155145-01 155146-01 155147-01 155148-01 155149-01 155150-01 155151-01 155152-01 155153-01 155154-01 155155-01 155156-01 155157-01 155159-01 155160-01 155161-01 155163-01 155165-01 155166-01 155167-01 155168-01 155169-01 155171-01 155288-01 155293-01 155294-01 155299-01 155302-01 155303-01 155304-01 155305-01 155310-01 155311-01 169-03 169-04 169-05 169-06 169-07 169-08 169-09 169-10 169-100 169-101 169-102 169-103 169-104 169-105 169-106 169-107 169-108 169-109 169-11 169-110 169-111 169-112 169-113 169-114 169-115 169-12 169-120 169-124 169-125 169-127 169-128 169-129 169-13 169-131 169-132 169-137 169-138 169-139 169-14 169-140 169-141 169-142 169-143 169-144 169-145 169-15 169-150 169-151 169-152 169-155 169-156 169-159 169-16 169-160 169-161 169-162 169-163 169-164 169-18 169-19 169-20 169-21 169-22 169-23 169-24 169-25 169-26 169-27 169-28 169-29 169-30 169-31 169-32 169-33 169-34 169-35 169-36 169-37 169-38 169-39 169-40 169-41 169-42 169-43 169-44 169-45 169-46 169-47 169-48 169-49 169-50 169-51 169-52 169-53 169-54 169-55 169-56 169-57 169-58 169-59 169-60 169-61 169-62 169-63 169-64 169-65 169-66 169-67 169-68 169-69 169-70 169-71 169-72 169-73 169-74 169-75 169-76 169-77 169-78 169-79 169-80 169-81 169-82 169-83 169-84 169-85 169-86 169-87 169-88 169-89 169-90 169-91 169-92 169-93 169-94 169-95 169-96 169-97 169-98 169-99
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·September 30, 2025