24 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EPSILON DURASUL CONSTRAINED ACETABULAR LINER
FDA 510(k)
FDA Class 2
·Orthopedic
Auvard 3.0lbs, 75° angle, Blade
FDA UDI
MEDGYN PRODUCTS, INC.·M803030923·Auvard 3.0lbs, 75° angle, Blade 1 1/2" x 3 1/4"...
9 x 23mm Citrelock ACL Implant
FDA UDI
Acuitive Technologies, Inc.·00810027270610·
Zavation
FDA UDI
Zavation LLC·00842166108615·PLIF-C 9x23 Convex -14
Zavation
FDA UDI
Zavation LLC·00842166108578·PLIF-C 9x23 Convex -10
Zavation
FDA UDI
Zavation LLC·00842166108592·PLIF-C 9x23 Convex -12
Zavation
FDA UDI
Zavation LLC·00842166108639·PLIF-C 9x23 Convex -16
Zavation
FDA UDI
Zavation LLC·00842166108622·PLIF-C 9x23 Convex -15
Zavation
FDA UDI
Zavation LLC·00842166108554·PLIF-C 9x23 Convex -08
Zavation
FDA UDI
Zavation LLC·00842166108585·PLIF-C 9x23 Convex -11
Zavation
FDA UDI
Zavation LLC·00842166108561·PLIF-C 9x23 Convex -09
Zavation
FDA UDI
Zavation LLC·00842166108608·PLIF-C 9x23 Convex -13
KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E
FDA 510(k)
FDA Class 2
·Cardiovascular
APEX MODULAR ZIRCONIA FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 2, 2013
SAGITTAL BLADE
FDA Adverse Event
Injury
·STRYKER IRELAND LTD.·Product code GFA·March 21, 2011
GE OEC 8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008
Eye and Ear Dropper, Product Code 67082
FDA Enforcement
Class II
·Ongoing·Apothecary Products, LLC·June 21, 2023
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
Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 7627 SCLP, 7628 SCM, 7629 SCF, 7630 SCX: 7607 SSM/UDI: Natrelle Inspira SSM 140cc BI (US) 10888628032835, Natrelle Inspira SSM 175cc BI (US) 10888628032842, Natrelle Inspira SSM 195cc BI (US) 10888628032859, Natrelle Inspira SSM 210cc BI (US) 10888628032866, Natrelle Inspira SSM 240cc BI (US) 10888628032873, Natrelle Inspira SSM 255cc BI (US) 10888628032880, Natrelle Inspira SSM 275cc BI (US) 10888628032897, Natrelle Inspira SSM 295cc BI (US) 10888628032903, Natrelle Inspira SSM 310cc BI (US) 10888628032910, Natrelle Inspira SSM 330cc BI (US) 10888628032927, Natrelle Inspira SSM 345cc BI (US) 10888628032934, Natrelle Inspira SSM 360cc BI (US) 10888628032941, Natrelle Inspira SSM 375cc BI (US) 10888628032958, Natrelle Inspira SSM 405cc BI (US) 10888628032965, Natrelle Inspira SSM 445cc BI (US) 10888628032972, Natrelle Inspira SSM 485cc BI (US) 10888628032989, Natrelle Inspira SSM 520cc BI (US) 10888628032996, Natrelle Inspira SSM 560cc BI (US) 10888628033009, Natrelle Inspira SSM 600cc BI (US) 10888628033016, Natrelle Inspira SSM 640cc BI (US) 10888628033023, Natrelle Inspira SSM 685cc BI (US) 10888628033030, 7608 SSF/UDI: Natrelle Inspira SSF 180cc BI (US) 10888628033054, Natrelle Inspira SSF 200cc BI (US) 10888628033061, Natrelle Inspira SSF 220cc BI (US) 10888628033078, Natrelle Inspira SSF 240cc BI (US) 10888628033085, Natrelle Inspira SSF 265cc BI (US) 10888628033092, Natrelle Inspira SSF 295cc BI (US) 10888628033108, Natrelle Inspira SSF 325cc BI (US) 10888628033115, Natrelle Inspira SSF 335cc BI (US) 10888628033122, Natrelle Inspira SSF 345cc BI (US) 10888628033139, Natrelle Inspira SSF 365cc BI (US) 10888628033146, Natrelle Inspira SSF 385cc BI (US) 10888628033153, Natrelle Inspira SSF 415cc BI (US) 10888628033160, Natrelle Inspira SSF 450cc BI (US) 10888628033177, Natrelle Inspira SSF 485cc BI (US) 10888628033184, Natrelle Inspira SSF 520cc BI (US) 10888628033191, Natrelle Inspira SSF 560cc BI (US) 10888628033207, Natrelle Inspira SSF 605cc BI (US) 10888628033214, Natrelle Inspira SSF 650cc BI (US) 10888628033221, Natrelle Inspira SSF 695cc BI (US) 10888628033238, Natrelle Inspira SSF 745cc BI (US) 10888628033245, Natrelle Inspira SSF 770cc BI (US) 10888628033252, 7609 SSX/UDI: Natrelle Inspira SSX 200cc BI (US) 10888628033269, Natrelle Inspira SSX 225cc BI (US) 10888628033276, Natrelle Inspira SSX 255cc BI (US) 10888628033283, Natrelle Inspira SSX 285cc BI (US) 10888628033290, Natrelle Inspira SSX 310cc BI (US) 10888628033306, Natrelle Inspira SSX 340cc BI (US) 10888628033313, Natrelle Inspira SSX 375cc BI (US) 10888628033320, Natrelle Inspira SSX 400cc BI (US) 10888628033337, Natrelle Inspira SSX 420cc BI (US) 10888628033344, Natrelle Inspira SSX 445cc BI (US) 10888628033351, Natrelle Inspira SSX 470cc BI (US) 10888628033368, Natrelle Inspira SSX 495cc BI (US) 10888628033375, Natrelle Inspira SSX 525cc BI (US) 10888628033382, Natrelle Inspira SSX 545cc BI (US) 10888628033399, Natrelle Inspira SSX 560cc BI (US) 10888628033405, Natrelle Inspira SSX 580cc BI (US) 10888628033412, Natrelle Inspira SSX 615cc BI (US) 10888628033429, Natrelle Inspira SSX 650cc BI (US) 10888628033436, Natrelle Inspira SSX 700cc BI (US) 10888628033443, Natrelle Inspira SSX 750cc BI (US) 10888628033450, Natrelle Inspira SSX 800cc BI (US) 10888628033467, 7513 SRL/UDI: Natrelle Inspira SRL 110cc BI (US) 10888628006645, Natrelle Inspira SRL 125cc BI (US) 10888628006652, Natrelle Inspira SRL 140cc BI (US) 10888628006669, Natrelle Inspira SRL 170cc BI (US) 10888628006676, Natrelle Inspira SRL 200cc BI (US) 10888628006683, Natrelle Inspira SRL 230cc BI (US) 10888628006690, Natrelle Inspira SRL 260cc BI (US) 10888628006706, Natrelle Inspira SRL 290cc BI (US) 10888628006713, Natrelle Inspira SR
FDA Enforcement
Class III
·Terminated·Allergan PLC·December 25, 2019