22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAYMAN BUTTRESS PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481123283·LOCATOR F-Tx Abutment For 5.0mm Camlog Connecti...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481113369·LOCATOR R-Tx Abutment for 5.0mm Camlog Connecti...
LEONE SPA
FDA UDI
LEONE SPA·08033707065654·INTRAORAL ELASTICS 2,5 oz 1/4" red
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·00842331100963·Rhoton Bipolar Bayonet Forceps, round handle, 0...
Symmetry Rhoton®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482140475·Bayonet Bipolar Forcep Round Handle, 0.3mm Tip ...
Azur Pure Helical
FDA UDI
Microvention, Inc.·00810170018091·Azur
Symmetry Olsen
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00841785112942·
HBS HEADLESS BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
HARDY DISK, PENICILLIN, 10 UNITS
FDA 510(k)
FDA Class 2
·Microbiology
STYLE 20 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·February 9, 2026
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTM·April 24, 2013
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008
UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·May 6, 2011
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 2024
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code OJA·June 11, 2024
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·May 4, 2016