13 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
KALAZAR DETECT
FDA 510(k)
FDA Class 1
·Microbiology
Safco Surgical Length Bur
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310234833·Safco surgical length bur, #2 round RA, 5-pack
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120234831·Carbide, round, rosehead, fast cutting, green ring
MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)
FDA 510(k)
FDA Class 2
·Cardiovascular
INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 2, 2019
DERMABOND ADVANCED
FDA Adverse Event
Injury
·ETHICON, INC.·Product code MPN·March 27, 2013
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 1, 2011
CIBA VISION MEMORY LENS
FDA Adverse Event
Malfunction
·CIBA VISION CORP.·Product code HQL·April 2, 2008
ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHA·January 7, 2012
AGENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OOB·May 16, 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