19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ASAHI Corsair Pro
FDA 510(k)
FDA Class 2
·Cardiovascular
Symmetry Rochester-Pean
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482056073·Symmetry® Forceps, Rochester-Pean Hemostatic, C...
Ardis®
FDA UDI
ZIMMER SPINE, INC.·00889024334052·
Ardis®
FDA UDI
ZIMMER SPINE, INC.·00889024334786·
PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS
FDA 510(k)
FDA Class 2
·Orthopedic
ACCUREX
FDA 510(k)
FDA Class 2
·Radiology
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·March 31, 2020
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·June 17, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·September 17, 2008
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·May 26, 2022
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·October 10, 2020
LOCKSCR Ø5 SELF-TAP L60 SST
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·January 21, 2020
LCP(TM) DISTAL FEMUR PLATE 13 HOLES/316MM-RIGHT
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·March 16, 2020
BONE PIN, 3.2MM X 140MM, STERILE 2 PACK
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code OLO·January 23, 2017
4.5MM CORTEX SCREW SELF-TAPPING 38MM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·January 23, 2020
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
dS Breast 7ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024