17 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REVERSE SHOULDER PROSTHESIS MONOBLOCK
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00845694003216·1.6mm Pre-bent Plate, 2mm step, Left
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450186770·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450186763·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694064019·1.6 OSA 2mm Pre-bent Left Plate Sterile Qty 2
HA PMI FEMORAL HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
E1 ANTIOXIDANT INFUSED TECHNOLOGY
FDA 510(k)
FDA Class 2
·Orthopedic
SEVEN-DAY INFUSOR
FDA Adverse Event
Malfunction
·IRVINE·Product code MEB·March 8, 2001
VERSAFITCUP DM CUP 54
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·July 12, 2013
AMISTEM H, HA COATED STEM SIZE 3 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 22, 2016
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 24, 2013
FLEXCATH ADVANCE STEERABLE SHEATH
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code DRA·September 30, 2014
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code FYD·May 5, 2011
AMISTEM H FEMORAL CEMENTLESS STEM SIZE 3 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 25, 2015
syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021
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
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015