24 results
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21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Shoreline Cervical Interbody RT System
FDA 510(k)
FDA Class 2
·Orthopedic
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515027503·Weitlaner-Beckman Ret., 3 x 4 blunt, 8" Hinged
AGILIS ES STEERABLE INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
AGILIS NXT STEERABLE INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·February 12, 2020
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019
FUJIFILM DOUBLE BALLOON ENDOSCOPES EN-450T5/W
FDA Adverse Event
Death
·FUJIFILM CORPORATION·Product code FDA·January 26, 2024
UNKNOWN_CMF_PRODUCT
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS-FREIBURG·Product code JEY·June 21, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Injury
·CORIN AUSTRALIA PTY LTD·Product code LZO·December 9, 2019
CORIN OPTIMIZED POSITIONING SYSTEM
FDA Adverse Event
Malfunction
·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026