26 results · 26ms · Sources: EU EUDAMED, US FDA

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Renamel Bulkfill

FDA 510(k)
FDA Class 2 ·Dental

Comprehensive® SRS

FDA UDI
Biomet Orthopedics, LLC·00880304540477·

PMT® Halo Systems

FDA UDI
PMT CORPORATION·00650551112648·HALO, 1203-5 VEST LARGE, COOLMAX LINER, 1211-1 ...

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970423·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970393·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970416·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970409·

ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System

FDA 510(k)
FDA Class 2 ·Orthopedic

SV DBS VRAIN ARRAY

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

PRECISION LINK

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code NBW·October 16, 2008

FLOCONTROL ARTHROSCOPY PUMP (HAND CONTROL INCLUDED

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code HRX·July 12, 2011

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·July 8, 2013

COMPR SRS IC SEG - 60MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDC·April 16, 2020

COMPR SRS MOD RGX AUG - LG

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDC·April 16, 2020

COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PHX·October 2, 2025

COMPREHENSIVE REVERSE SHOULDER SYSTEM VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PHX·October 2, 2025

COMPR SRS PROX BDY - LG 42MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDC·April 16, 2020

VERSA-DIAL 46X21X50 HUM HEAD

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HSD·August 18, 2020

ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015