16 results
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39ms
·
Sources: EU EUDAMED, US FDA
LORENZE EXTERNAL MANDIBULAR DISTRACTOR
FDA 510(k)
FDA Class 2
·Dental
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0316920·Probe, 1.75" Egg, Steffee, Long, Straight, Impact
20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SILMED NASAL SEPTAL BUTTON
FDA 510(k)
FDA Unclassified
·Unknown
FIRSTPASS MINI LEFT
FDA Adverse Event
Malfunction
·ARTHROCARE CORP.·Product code NBH·December 12, 2019
MARKERS
FDA Adverse Event
Malfunction
·PRAXIM·Product code HAW·January 3, 2007
NAVLOCK
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code KCT·October 15, 2025
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·April 2, 2013
QUADRA ASSURA CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·August 22, 2014
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·March 18, 2011
4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION
FDA Adverse Event
Injury
·SYNTHES USA·Product code HTW·October 14, 2016
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024