11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123014·K-WIRE - SINGLE TROCAR 2.0mm DIA x 150mm
Membrane for E7077 electrode
FDA UDI
Radiometer Medical ApS·05700699420664·D7077 Lac membrane box (4 units) for ABL7XX/8XX
KLSA MARTIN HAND DISTRACTOR
FDA 510(k)
FDA Class 2
·Orthopedic
AERO-LL LUMBAR CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BABY CONTROL MOBILE INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·February 4, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 5, 2014
S-ROM SLEEVE PRX ZTT, 18F-LRG
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code LPH·December 8, 2010
AERO LL FIXATION ANCHOR, 50MM
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code OVD·March 25, 2019
Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·October 9, 2013
PKG, MIXTER FORCEPS, P/N 0250080249. 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