23 results
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32ms
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Sources: EU EUDAMED, US FDA
MICRESURGICAL TRAY, SM.,MED., & LG.
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VITROS
FDA UDI
ORTHO CLINICAL DIAGNOSTICS·10758750000708·VITROS Immunodiagnostic Products Total T4 Range...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306810183·Hoyos Basket Cannula, 9G x 25cm, 60cc
ACUMED
FDA UDI
Acumed LLC·10806378041594·Lkg RH Tray Screw Caddy
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306835438·Hoyos Basket Cannula, 9G x 10cm, 60cc
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197491464·Titanium Blade
51x152...
KORONA
FDA UDI
HNM TOTAL RECON LLC·00841742100685·KORONA Quad Staple - (L)15mm, 18mmx16mm
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306835445·Pre-Assembled Hoyos Basket Cannula, 9G x 25cm, ...
SECURMIX
FDA 510(k)
FDA Class 2
·General Hospital
ZIMMER MIS LIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INJ, OPTIV, MULI
FDA Adverse Event
Malfunction
·LIEBEL- FLARSHEIM·Product code IZQ·January 16, 2026
BIODESIGN 4-LAYER TISSUE GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH, INC.·Product code PAG·April 3, 2014
2520274-2012-02439
FDA Adverse Event
Injury
·Product code KWQ·October 22, 2012
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 27, 2015
30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Bag Hanger, REF: CL3011T; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, Drop-In Red Cap, REF: CL3020; 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, Drop-In Red Cap, REF: CL3028; 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros, Bag Hanger, Drop-In Red Cap, REF: CL3028T; 42" (107 cm) Appx 5.2 ml, Admin Set w/20 Drop In-Line Chamber, ChemoLock w/Red Cap, Spiros, Bag Hanger, Drop-In Red Cap, REF: CL3361; Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock; Spinning Spiros w/Red Cap, REF: CL3538; Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, Spiros; ChemoLock; ChemoLock Universal Vented Vial Spike; Bag Hanger, REF CL3929; 8.5" (22 cm) Appx 1.0 ml, Ext Set w/MicroClave Clear, ChemoLock Port, Spiros w/Red Cap, Clamp, REF: CL3931; 7.5" (19 cm) Appx 1.1 ml, Bifuse Ext Set w/ChemoLock Port, ChemoClave, Spiros, 2 Clamps, REF: CL3932; 30 IN(76cm)APPX 2.1ml, EXT SET w/ChemoLock w/RED CAP, Spiros RED CAP, REF: CL3935; Oncology Kit w/ChemoLock w/ChemoClave; Spinning Spiros w/ Red Cap, REF: CL3941; Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock w/Red Cap, Vented Cap; ChemoLock Port w/Bag Spike; Spiros w/Red Cap, REF: CL3946; Oncology Kit, ChemoLock Bag Spike w/Additive Port, Vented Cap, Spiros, REF: CL3948; Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros, ChemoLock, Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960; Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros, ChemoLock, Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960T; 60" (152 cm) Appx 7.4 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Chamber, Spiros w/Red Cap, Bag Hanger, REF: CL4100; 30" (76 cm) Appx 3.6 ml, Admin Set w/20 Drop In-Line Drip Chamber, ChemoLock Additive Port, Spiros w/Red Cap, REF: CL4131; 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer, REF: CL4151; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, Spiros w/Red Cap, Drop-In ChemoLock Injector, Bag Hanger, REF: CL3978
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·December 30, 2020
Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either armrest can easily be detached. Supporter includes seat ring and lid.
FDA Recall
Terminated
·Etac Supply Center Ab Langgatan 12 Anderstorp Sweden·Product code ILS·June 15, 2015
Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Recall
Open, Classified
·Electro Medical Systems SA Chemin De La Vuarpilliere·Product code ELC·March 13, 2024
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Recall
Open, Classified
·Electro Medical Systems SA Chemin De La Vuarpilliere·Product code ELC·March 13, 2024
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Recall
Open, Classified
·Electro Medical Systems SA Chemin De La Vuarpilliere·Product code ELC·March 13, 2024
REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
FDA Recall
Terminated
·LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC·Product code MUU·August 8, 2017