16 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT
FDA 510(k)
FDA Class 2
·Immunology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668109052·DALK AIR INJECTION CANNULA 27GA
GRAMS POLYESTER NONABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
UNSPECIFIED BD SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·January 8, 2018
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·April 23, 2013
ALARIS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FRN·April 21, 2011
RIATA ST PASSIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 3, 2021
TRI-LOCK BPS SZ 4 HI OFFSET
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 4, 2015
TRI-LOCK BPS SZ 7 STD OFFSET
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC·Product code KWA·November 4, 2015
979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 7, 2018
14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 7, 2018
Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt. orthopedic instrument
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 7, 2018
Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 4, 2018
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