34 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ReLine
FDA UDI
Nuvasive, Inc.·00195377047571·RELINE-O Trial, 6mm H Ang Left L-pop
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00142006020·A2
DOYEN SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896083813·DOYEN SCISSORS HEAVY CURVED SERRATED BLADE POWE...
ELMED
FDA UDI
ELMED INCORPORATED·00842180172418·SHORT ADAPTER FOR VALTCHEV UTERINE MOBILIZER
OsteoMed
FDA UDI
OSTEOMED LLC·00845694016292·M4 Mid-Face Plate Organizer, Series II
Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Enforcement
Class II
·Ongoing·Oto Med Inc·May 12, 2021
PROTEGE WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
SYNTHES PILON PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
MICROSCAN DRIED POS MIC PANEL TYPE 20A
FDA Adverse Event
Malfunction
·DADE BEHRING, INC.·Product code LTT·August 1, 2005
RENU WITH MOISTURELOC
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code LPN·August 29, 2007
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Malfunction
·COSTA RICA·Product code LIT·March 15, 2006
STEELCRAFT, INC.
FDA Adverse Event
Malfunction
·STEELCRAFT, INC.·Product code FOX·March 23, 2004
ANEURX XPEDIENT ILIAC SG
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·October 20, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
SIGMA 300 DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·December 10, 2013
PARIETEX UGYTEX PP POSTERIOR KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·December 23, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·October 24, 2014
KAPPA 900 DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
BATTERY 14.8V, 6.3 AH LI-ION BATTERY
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 4, 2015