17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP
FDA 510(k)
FDA Class 2
·Dental
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885380076275·0.8mm Guide Wire 100mm
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR76000831001·Lingual cleat on pad max. right / mand. left
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702450309·Elvarex 2/Knee High/Slant-Closed Toe/Dotted 5 c...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197029193·Iris Scissors
curved...
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROPOXYPHENE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·May 10, 2018
SETROX S 60
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·April 29, 2013
DUROM HIP
FDA Adverse Event
Other
·ZIMMER GMBH·Product code KWA·April 29, 2011
SYNCRHOMED II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·July 24, 2008
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·February 10, 2025
POLIGRIP CUSHION COMFORT
FDA Adverse Event
Injury
·ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH·Product code KOT·August 20, 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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015