26 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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