16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
Implant Prosthetics
FDA UDI
Preat Corporation·00842092103081·CAMLOG® Screw-Line-compatible 4.3mm X 4.5mm Tit...
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET
FDA 510(k)
FDA Class 2
·General Hospital
MIO ADVANCE
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 19, 2024
CERTAIN GOLD-TITE TM HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·June 26, 2017
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·March 14, 2013
BARD PORT IMPLANTED PORT WITH GROSHONG CATHETER
FDA Adverse Event
Injury
·BARD ACCESS SYSTEMS·Product code LJT·February 21, 2011
COAGUCHEK XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·February 21, 2008
LIGHTSHEER EC
FDA Adverse Event
Injury
·RH USA, INC.·Product code GEX·August 28, 2012
IFS ADVANCED FEMTOSEC LASER
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC·Product code GEX·June 9, 2022
CER BIOLOXD OPTION HD 40MM
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code LPH·August 3, 2020
OXF UNI CMNTLS TIB SZ C LM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·August 19, 2021
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022