18 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARCOS TROCHANTER BUTTON
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00845694003346·Buttress Plate Left
TISSUE FORCEPS GILLIES 1x2 TEETH 6"
FDA UDI
W.H. Holden, Inc.·D9281300630·
PARALLEL BAR,***W/63***,10' HT ADJ(3pc)
FDA UDI
Hausmann Enterprises, LLC·00840314800053·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694064279·1.6 OSA Buttress Left Plate Sterile Qty 2
HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL
FDA 510(k)
FDA Class 2
·Cardiovascular
SOVEREIGN SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AMISTEM H, HA COATED STEM SIZE 3 LAT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 12, 2017
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 26, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 6, 2019
GREENLIGHT HPS BP FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·May 20, 2013
SIENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·June 16, 2011
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·August 19, 2008
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019
AMISTEM H CEMENTLESS FEMORAL STEM SIZE 3 LAT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 4, 2015
EQUINOXE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·January 9, 2024
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