15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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U2 HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089447138·
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213033313·Coupling Treatment Tube for Metal Needles (29)
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089466481·
MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY
FDA 510(k)
FDA Unclassified
·Unknown
ENDOFORM DENTAL TEMPLATE
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 13, 2026
HT70 PLUS VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS INC.·Product code CBK·June 2, 2017
3.5MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·August 15, 2017
S3 EX - 3005
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 14, 2013
ASR
FDA Adverse Event
Malfunction
·DEPUY·Product code KWA·May 31, 2011
TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code LQC·August 13, 2008
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021