19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PureGuard
FDA UDI
PURELIFE, LLC·D79010240041·Large, Soft, nitrile powder-free, Textured fing...
Halyard
FDA UDI
Avanos Medical, Inc.·10680651102406·HALYARD* Laparoscopic Introducer Kit for Gastro...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0140040·Driver Shaft, T30 Split Tip Double End Cap Starter
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197470858·Farrior Aural Speculum, round
Ø 8.5m...
CLINDATALINK VERSION 1.0 FOR SPIROMETRY
FDA 510(k)
FDA Class 2
·Anesthesiology
VALVED PEELABLE INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
COYOTE¿ ES
FDA Adverse Event
Malfunction
·Product code LIT·March 27, 2013
LUMAX 540 DR-T
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code MRM·February 14, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP.
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008
EU ENT4.5MMD 22MML WNO DSTL TP
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·May 8, 2024
ESSENZ
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTQ·October 17, 2024
ESSENZ
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTQ·October 30, 2024
ESSENZ
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTQ·October 29, 2024
SYSMEX PS-10
FDA Adverse Event
Malfunction
·SYSMEX CORPORATION·Product code PER·February 6, 2025
SYSMEX PS-10
FDA Adverse Event
Malfunction
·SYSMEX CORPORATION·Product code PER·January 10, 2025
AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30
FDA Recall
Terminated
·Abbott Laboratories Diagnostic Div·Product code CDQ·November 24, 2003
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018