18 results · 28ms · Sources: EU EUDAMED, 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