14 results
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24ms
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Sources: EU EUDAMED, US FDA
QUANTIMUNE E3 RIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CODMAN®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780516644·CODMAN® Non Stick Mirror Finish Bayonet Bipolar...
CODMAN
FDA UDI
Cerenovus, Inc.·10886704080855·CODMAN Non Stick Mirror Finish Bayonet Bipolar ...
CODMAN MALIS
FDA UDI
Cerenovus, Inc.·10886704039037·CODMAN MALIS Non Stick Mirror Finish Bayonet Bi...
PRECISA BIOPSY NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
SYMBIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 21, 2014
UNKNOWN DEPUY FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWB·October 24, 2012
CONSULTA
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 17, 2010
WITTICH NITINOL STONE BASKET
FDA Adverse Event
Malfunction
·COOK INC·Product code LQR·February 20, 2019
WITTICH NITINOL STONE BASKET
FDA Adverse Event
Malfunction
·COOK INC·Product code LQR·February 20, 2019
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
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194; CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054; CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065; CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018