17 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00530351·
Premier REAMERS
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6919053035·REAMERS PKG 6 25MM 25
MicroAire®
FDA UDI
Microaire Surgical Instruments LLC·00847399005274·SST TWIST DRILL, AO TYPE, 3.5mm DIA. X 85mm
NA
FDA UDI
STERILMED, INC.·10888551001861·DRILL BIT TWIST A. O. SYNTHES STYLE
CLARREN HELMET
FDA 510(k)
FDA Class 2
·Neurology
GUARDIAN LIMB SALVAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523107469·Pre Lordosed Rod 5.5mm diameter 35mm length CP ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523107704·Pre Lordosed Rod 5.5mm diameter 35mm CoCr
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523106875·Pre Lordosed Rod 5.5mm diameter 35mm length Ti6...
Valkyrie Thoracic Fixation System
FDA UDI
J.M. Longyear Manufacturing, LLC·00810071390142·Driver Bit, No Shoulder
MEDISORB EX
FDA Adverse Event
Injury
·VYAIRE OY·Product code CBL·September 25, 2023
ARCHITECT ANTI-HBS
FDA Adverse Event
Malfunction
·ABBOTT IRELAND·Product code LOM·April 11, 2013
NOVASURE
FDA Adverse Event
Malfunction
·CYTYC SURGICAL PRODUCTS. A HOLOGIC COMPANY·Product code MNB·May 15, 2008
SPRINT QUATTRO
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 13, 2011
Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·January 11, 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