16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Flexitouch System
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526781733·LUMBAMED FACET 3 POINT SILVER VI
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197067362·Senn Retractor, blunt
6,0x13...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197067379·Wassmund Retractor
20.0cm
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107286·TRIAL 90-SRK-170216 POLY UCCS 2X16MM
NA
FDA UDI
aap Implantate AG·04042409038006·Cleaning wire ø1.6, CS 4.5
EXPEDIUM SYSTEM, VIPER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VARI-LASE BRIGHT TIP FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 29, 2023
PHILIPS SONICARE
FDA Adverse Event
Malfunction
·PHILIPS ORAL HEALTHCARE·Product code JEQ·July 24, 2018
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 14, 2013
KINETRA
FDA Adverse Event
Other
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·July 5, 2011
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·September 11, 2008
ALINITY C PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·April 3, 2025
Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169540521); and Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169641006) (Japan). The percutaneous pin adapter is a component of the StealthAir Frame Assembly.
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.·December 25, 2019
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024