21 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CoRoent
FDA UDI
Nuvasive, Inc.·00887517288332·CoRoent® XLCT, 16x18x50mm 10°
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317300751·
NA
FDA UDI
MAKO SURGICAL CORP.·00848486001346·CHECKPOINT KIT
OsteoMed
FDA UDI
OSTEOMED LLC·00845694052443·1.6mm Twist Drill, 5mm STOP, Hex Shank
Flexitron
FDA UDI
Nucletron B.V.·08717213021518·Flexitron Transfer Tube Set CT/MR GYN
Rhythmlink®
FDA UDI
RHYTHMLINK INTERNATIONAL, LLC·00816312024708·50 Monopolar Needle Electrodes, EMG, 50mm x 26g
Chalgren
FDA UDI
CHALGREN ENTERPRISES·00816020020108·Monopolar Needle Electrode, EMG, 50mm x 26g
ZYSTON ARC INTERBODY SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR
FDA 510(k)
FDA Class 2
·Anesthesiology
Tandry Locking Plate System
FDA UDI
MICROWARE PRECISION CO., LTD.·04719873098033·2.4mm Locking Volar Distal Radius Plate, 5 Hole...
LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 Ø11X380MM X 125°
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS-KIEL·Product code HSB·April 12, 2013
TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 14, 2012
SUMBIQ DCHANNEL 3.01
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 7, 2013
*
FDA Adverse Event
Other
·I-FLOW CORP.·Product code FRN·June 4, 2008
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code FMK·June 2, 2011
UNKNOWN LUMBAR IMPLANT
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·April 11, 2022
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
XP-XP Tibial Tray - Interlok 67 mm Item # 195753
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019