16 results · 39ms · Sources: EU EUDAMED, US FDA

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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