13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aneroid Sphygmomanometer
FDA 510(k)
FDA Class 2
·Cardiovascular
36M - MSHA Miners
FDA UDI
Certified Safety Manufacturing, Inc.·00766588026206·36M - MSHA Miners
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113875·VISCO INJECTION CANNULA 30GA ANG 10MM
Needle aspiration and injection
FDA UDI
KATENA PRODUCTS, INC.·00841668113615·PERIBULBAR NEEDLE 23GA 32MM
Luna® G3 BPAP 25A
FDA 510(k)
FDA Class 2
·Anesthesiology
NSI HEXED AND NON-HEXED IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
TPRLC 133 T1 PPS HO 10X140MM 0MM T1
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·April 13, 2018
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·October 16, 2008
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 3, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
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
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018