16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STARBAND AND STARLIGHT
FDA 510(k)
FDA Class 2
·Neurology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017743·K-Wire, Double Ended, Trocar Point, Diameter Si...
Fuji Cervical Plate System
FDA UDI
Altus Spine, LLC·B41711403531·53mm Level 3 Cervical Plate System - Fuji
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197382786·No-Scalpel Vasectomy Mini Fixator Ring-
forcep...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197382779·No-Scalpel Vasectomy forceps 5", 12.5cm
cvd. ,...
FLIGHT SOCK
FDA 510(k)
FDA Class 2
·General Hospital
SPINEWAND SURGICAL DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 3, 2014
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 31, 2013
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·June 16, 2011
HISTOACRYL FLEXIBLE PACK 5
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL SA·Product code MPN·February 11, 2020
GALAFLEX
FDA Adverse Event
Injury
·TEPHA, INC·Product code OOD·February 28, 2020
HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML
FDA Adverse Event
Injury
·B. BRAUN SURGICAL SA·Product code MPN·February 26, 2020
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
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
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022