19 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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Vitalograph Model 6300 micro
FDA 510(k)
FDA Class 2
·Anesthesiology
Monza Cervical Plate System
FDA UDI
Altus Spine, LLC·B41711602531·53mm Cervical Plate, 2 Level
Denovo general purpose dental molar band
FDA UDI
Denovo Dental, Inc.·00810059290464·Denovo general purpose dental molar band - Mand...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197416818·Nervehook LOEPRECHT 3 mm diam.
150 mm...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197416795·Nervehook LOEPRECHT 2 mm diam.
150 mm...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197416801·Nervehook LOEPRECHT 2.5mm diam.
150 mm...
VISUMAX LASER KERATOME
FDA 510(k)
FDA Class 2
·Ophthalmic
STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.
FDA 510(k)
FDA Class 2
·Orthopedic
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 21, 2023
GORE DRYSEAL FLEX INTRODUCER SHEATH
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DYB·October 19, 2020
AMISTEM H, HA COATED STEM SIZE 4 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 27, 2017
GORE® DRYSEAL FLEX INTRODUCER SHEATH
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DYB·October 6, 2016
DOUBLE MOBILITY HC LINER 28/DMG
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·March 30, 2017
CAUTERY HOOK TIP
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 10, 2013
HS III PROXIMAL SEAL SYSTEM 4.3MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·June 2, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
GORE® DRYSEAL FLEX INTRODUCER SHEATH
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DYB·May 30, 2023
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025