19 results · 23ms · Sources: EU EUDAMED, 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