10 results
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17ms
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Sources: EU EUDAMED, US FDA
STREPTOCOCCUS PNEUMONIAE CONTROL
FDA 510(k)
FDA Class 1
·Microbiology
NA
FDA UDI
Richard Wolf GmbH·04055207020944·INSERT for irrigation and insufflation with te...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690191377·Patella Resection Cover Size 32
LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401
FDA 510(k)
FDA Class 2
·Neurology
UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE
FDA 510(k)
FDA Class 2
·Dental
FIRE STAR RX PTCA BALLOON CATHETER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code LOX·May 30, 2014
PRINEO SKIN CLOSURE SYSTEM
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OMD·November 20, 2012
AU643-02E CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMA K.K.·Product code JJE·September 21, 2010
PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. 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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018