11 results
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28ms
·
Sources: EU EUDAMED, US FDA
OSTEOMED ALVEOLAR DISTRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
3D
FDA UDI
Rmo, Inc.·00885797100184·3D PALATAL APPLIANCE ASST OF 6
Hawkin Ambler Dilator
FDA UDI
MEDGYN PRODUCTS, INC.·M803030790·Hawkin Ambler Dilator 12-15 mm
DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORTISOL LIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 2, 2013
11.5FR X 13.5 MAHURKAR CATH
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MSD·March 22, 2011
ACCU-CHEK ULTRAFLEX INFUSION SET
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·April 17, 2008
M2A 38MMX58MM CUP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·June 13, 2022
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