14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFIED MERCY RETRIEVER, MODEL 90070
FDA 510(k)
FDA Class 2
·Cardiovascular
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704507485·
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290114694582·Digital Analog for Lab, NP, inc. Screw
KEYSTONE HIP
FDA 510(k)
FDA Class 2
·Orthopedic
NICOLET VERSALAB
FDA 510(k)
FDA Class 2
·Radiology
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·April 17, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 29, 2011
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 1, 2008
UNK BACTISEAL EVD CATHETER
FDA Adverse Event
Injury
·Product code JXG·December 12, 2017
BD DURASAFE¿ TRAY
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code CAZ·October 24, 2022
KYPHON KURVE BONE FILLER DEVICE 13GA
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code KIH·July 14, 2020
BD DURASAFE¿ TRAY
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code CAZ·October 27, 2022
TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01
FDA Enforcement
Class II
·Terminated·ArthroCare Corporation·April 13, 2016
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024