20 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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URGOTUL AG
FDA 510(k)
FDA Unclassified
·Unknown
Mini Sprint ®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70612201·Mini Sprint II Brackets FACE Evolution II Syste...
ENDOPATH SURESEAL REDUCER CAP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·June 17, 2020
TW DRILL 1.1X50MM 9MMSTOP W/NT
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·May 5, 2021
ADVIA CENTAUR XP TOXOPLASMA G (TOXO G)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·August 16, 2017
TW DRILL 1.1X50MM 9MMSTOP W/NT
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·February 17, 2021
PLUM A+ DRIVER ED 2
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 10, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 4, 2014
DST SERIES EEA ORVIL 25MM DEVICE
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·April 5, 2011
TW DRILL 1.1X50MM 9MMSTOP W/NT
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·November 29, 2021
BABY CONTROL MOBILE INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·November 15, 2016
TW DRILL 1.1X50MM 9MMSTOP W/NT
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·May 5, 2021
1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·August 5, 2020
LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HWX·June 17, 2020
ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·May 25, 2017
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018