13 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CONTACT LENS STORAGE CASE
FDA 510(k)
FDA Class 2
·Ophthalmic
Graves Vu-Max Titanium Medium
FDA UDI
MEDGYN PRODUCTS, INC.·M803030987·Graves Vu-Max Titanium Medium 4 1/2" (114mm)
E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
FDA registration
E.M.S. ELECTRO MEDICAL SYSTEMS S.A.·14 products·🇨🇭 Switzerland
VFSS IMAGER, MODEL SIS-300
FDA 510(k)
FDA Class 2
·Radiology
URS-1K (KETONE TESST)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 2, 2013
CONSTELLATION WITH LASER
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 4, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008
BACFIX ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020
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
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024