20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036028688·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450204979·
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345024113·Paddle Shaver, 16mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0103160·Shaver, Closed, 16mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197510943·Tebbet Breast Retractor
90x16m...
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code NTG·October 30, 2014
COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MERETEK UBT_LITE BREATH TEST FOR H. PYLORI
FDA 510(k)
FDA Class 1
·Microbiology
AEQ REV II GLENOID BASEPLATE DIA 25MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code PHX·July 1, 2025
AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·March 13, 2025
AEQ REV GLENOID BASEPLATE 29MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·March 6, 2025
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 2, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 15, 2014
HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 16, 2011
AEQUALIS REVERSED MULTIDIRECTIONAL GLENOID PLATE HA
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·March 25, 2024
D.4,5MM COMPRESSION SCREW L.32MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·January 7, 2025
D.4,5MM COMPRESSION SCREW L.23MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·January 7, 2025
AEQ REV GLENOID BASEPLATE 29MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·May 21, 2024
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 28, 2026