18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMF·October 3, 2019
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·October 30, 2017
BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·June 7, 2019
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 8, 2019
BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ 6MM X 31G NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·January 19, 2022
HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG
FDA 510(k)
FDA Class 2
·Microbiology
MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·January 24, 2019
VERTE-STACK SPINAL SYSTEM
FDA Adverse Event
Malfunction
·SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·January 21, 2010
BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·May 22, 2019
VERTE-STACK SPINAL SYSTEM
FDA Adverse Event
Malfunction
·SOFAMOR DANEK DEGGENDORF GMBH·Product code ODP·November 20, 2009
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 9, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 28, 2011
FINELINE II
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
FUJIFILM BALLOON BS-4
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDA·January 14, 2021
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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