23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SITE-RITE VISION ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Bur PM2-70 80K Carb Ø4.5 St
FDA UDI
Bien-Air Surgery SA·17630055503661·
GLOVER COOLEY BULLDOG CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896002180·GLOVER COOLEY BULLDOG CLAMP SPRING LOADED CURVED
GLOVER COOLEY BULLDOG CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921004020·GLOVER COOLEY BULLDOG CLAMP SPRING LOADED CURVED
OsteoMed
FDA UDI
OSTEOMED LLC·00845694089319·ISO Chin Plate, 10mm
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869604925·MOSS 100 Rod Holding Forceps Ø5.5mm 270mm
BIPAP AUTO BIFLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·January 30, 2025
SMOOTH-FLO CIRCUIT
FDA 510(k)
FDA Class 2
·Anesthesiology
SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST
FDA 510(k)
FDA Unclassified
·Unknown
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 8, 2011
AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·February 2, 2011
MAQUET HCU30 DEVICE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWC·July 29, 2015
HEYER-SCHULTE MAMMARY PROSTHESIS
FDA Adverse Event
V. MUELLER DIV. BAXTER HEALTHCARE CORP.·Product code FTR·November 16, 1994
OLYMPUS COLONOSCOPE
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code MNL·September 9, 2022
COBAS® WNV NUCLEIC ACID TEST FOR USE ON THE COBAS® 6800/8800 SYSTEMS
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 29, 2025
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 8, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 18, 2014
8800
FDA Adverse Event
Malfunction
·GE MED SYSTEMS (INDIA) PRIVATE LTD.·Product code JAA·May 13, 2011
Microdot Xtra blood glucose test strips
FDA Enforcement
Class II
·Ongoing·Cambridge Sensors Limited·August 28, 2019
Tracheostomy Tubes, Jackson Improved Short Stainless Steel with Adapter, item number 8100402 size 3,item number 8100040 size 4, item number 8100041 size 5, item number 8100229 size 6, item number 8100322 size 7, item number 8100374 size 8, item number 8100282 size 9, and item number 8100709 size10.
FDA Recall
Terminated
·Premier Dental Products Co·Product code JOH·August 5, 2004