14 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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FORCE FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033654·Baltic Denture System BDLoad BDLoad Lm6 PLSEbi...
INSTANT-VIEW Multi-Drugs of Abuse Urine Test (AMP, BZD, COC, MET, MOR300, THC)
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918001884·INSTANT-VIEW Multi-Drugs of Abuse Urine Test
(...
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GLYCA-DIRECT FRUCTOSAMINE
FDA 510(k)
FDA Class 2
·Hematology
033-654 OSCOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code DTB·May 9, 2019
RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION
FDA Adverse Event
Injury
·BAUSCH & LOMB INCORPORATED·Product code LPN·February 18, 2020
TRI LM/RL TIB AUG SZ4 5MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·April 3, 2013
INTEGRIS V3000
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZI·February 11, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 25, 2014
UNKNOWN PFM-R DISTAL STEM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·March 13, 2018
AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
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