16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GLADIATOR PLASMA CLASSIC HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306802980·Pitanguy Flap Demarcator, 25.5cm
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G2231103990·Dressing forceps, 3 7/8", straight, delicate, 1...
Trial Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964085987·Trial Procedure Kit
Trial Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964080548·Trial Procedure Kit
Trial Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964086083·Trial Procedure Kit
Trial Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964082627·Trial Procedure Kit
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964080531·Endo Carry-On Procedure Kit
4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A
FDA 510(k)
FDA Class 2
·Neurology
DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013
SYMBIQ DCHANNEL 3.01
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·September 16, 2014
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·June 1, 2011
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 28, 2026
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024