18 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VENTURI PHACO PACK
FDA 510(k)
FDA Class 2
·Ophthalmic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496033653·PERSONALITY 140 SHEER, SIZE 2XXL, NERO, GRADUAT...
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033653·Baltic Denture System BDLoad BDLoad ↓ Ln6 PLSEu...
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
BD MICRO-FINE¿+ PRO PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 11, 2022
CORNERSTONE-SR TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 11, 2018
ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM
FDA Adverse Event
Other
·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005
ASR ACETABULAR IMPLANT 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 3, 2013
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 17, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 25, 2014
CORNERSTONE-SR TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·September 7, 2017
BD ULTRA-FINE¿ 4MM PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 10, 2022
CORNERSTONE-SR® TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 6, 2025
CORNERSTONE-SR® TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 8, 2024
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024