57 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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Neodent Implant System
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699595·GENUMEDI PSS BLUE, SIZE VII
HHM
FDA UDI
Oticon A/S·05707131287649·H100V2, RITE 312 WL DBL HHM
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304238954·
OSS 11CM DIAPHYSEAL SEGMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·August 16, 2018
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962155349·DISPOSABLE BIPOLAR ABLATOR, 2.4MM, NON-ASPIRATI...
Patella Inlay Shaft Assembly
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215057039·
HNM Sports Medicine
FDA UDI
HNM STAINLESS, LLC.·00812171023333·DISPOSABLE BIPOLAR ABLATOR, 2.4MM, NON-ASPIRATI...
OSS 7CM SEGMENTAL FEMORAL LT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 6, 2019
BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
FDA 510(k)
FDA Class 2
·Hematology
MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·February 24, 2025
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·July 27, 2022
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·November 19, 2021
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·June 8, 2011
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 6, 2013
INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 7, 2014
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·November 23, 2021
HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
FDA Enforcement
Class II
·Ongoing·Bovie Medical Corporation·March 10, 2021
OSS SEGMENTAL STACKING ADAPTER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·February 21, 2020