13 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113912·VISCO INJECTION CANNULA 23GA
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331134524·crile-wood needle holder, serrated jaws, 6" (15...
STILLE Chisels
FDA UDI
Stille AB·07332339206451·CHISEL ORIGINAL STILLE 6 mm 16.5 cm 6.5 in
N LP(A) STANDARD SY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACRYLIC HERBST APPLIANCE
FDA 510(k)
FDA Class 2
·Dental
BD ULTRA-FINE¿ INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·August 8, 2023
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 28, 2023
LUMAX 540 HF-T
FDA Adverse Event
Death
·BIOTRONIK SE & CO. KG·Product code LWS·August 5, 2011
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·October 30, 2014
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013
BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMI·July 12, 2023
PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014