19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE
FDA 510(k)
FDA Class 1
·General Hospital
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547151·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547113·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547137·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547168·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547144·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547106·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547120·
TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
ILET BIONIC PANCREAS
FDA Adverse Event
Malfunction
·BETA BIONICS INC.·Product code QFG·January 3, 2026
ILET BIONIC PANCREAS
FDA Adverse Event
Injury
·BETA BIONICS INC.·Product code QFG·January 21, 2026
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code MND·March 10, 2011
ZIMMER CEMENT MIXING SYSTEM
FDA Adverse Event
Malfunction
·ZIMMER ORTHOPAEDIC SURG. PROD.·Product code JDZ·March 13, 2008
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code BWC·September 4, 2019
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022