13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Polyguard and Polyshield Safety IV Catheters
FDA 510(k)
FDA Class 2
·General Hospital
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158213807·FORCEPS DEBAKEY ATRAUMATIC TISSUE 1.5MM TIP STR...
MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
FDA 510(k)
FDA Class 1
·Clinical Toxicology
TIBIAL NAIL, STANDARD T2 TIBIA 9X300 MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 12, 2012
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·August 11, 2011
BONE SCREWS,CROSS-PIN,2.7X16MM,1/P
FDA Adverse Event
Malfunction
·STRYKER LEIBINGER FREIBURG·Product code KTT·November 6, 2014
UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·July 16, 2013
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 31, 2023
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 42MM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code KWQ·December 16, 2024
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 45MM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code KWQ·December 16, 2024
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025