16 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DAMON 4CLEAR
FDA 510(k)
FDA Class 2
·Dental
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810057371325·Platinum Stirrup Boot Pads, Set
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788023490·RX Coudé® Epidural Needle with Small Bore Conne...
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180514115·TLIF Shavers
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469
FDA 510(k)
FDA Class 1
·Clinical Toxicology
ALPCO MILENIA ANTI-TG EIA
FDA 510(k)
FDA Class 2
·Immunology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 25, 2024
NDEHP PRIMARY PLUM PREPIERCED Y
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·April 25, 2013
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LJT·November 4, 2015
SEE H-10
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·April 26, 2013
REMANUFACTURED RENAISSANCE STERILIZER
FDA Adverse Event
STERIS MEXICO, S. DE R.L. DE C.V.·Product code FLE·September 11, 2014
LIGASURE ADVANCE PISTOL GRIP
FDA Adverse Event
Injury
·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 29, 2011
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LJT·November 17, 2017
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LIT·May 23, 2016
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 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