11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABNORMAL GLYCOHEMOGLOBIN CONTROL
FDA 510(k)
FDA Class 2
·Hematology
ERA ANGLE 3.25MM IMP MICRO HEAD 13X3MM ACID ETCHED, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549109652·Designed for both transitional and long-term de...
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113462·SCLEROTOME BLADE #57 (BX/5)
!NSURE FECAL OCCULT BLOOD TEST
FDA 510(k)
FDA Class 2
·Hematology
M1 Surgical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 30, 2014
X-STOP IPD SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SPINE LLC·Product code NQO·October 22, 2010
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. HOMECARE PRODUCT, INC·Product code INI·January 8, 2013
CVSHEALTH COMFORT DENTAL GUARDS
FDA Adverse Event
Injury
·CVSHEALTH / CVS PHARMACY, INC.·Product code OBR·June 10, 2024
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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