14 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENGSTROM CARESTATION, ENGSTROM PRO
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257129494·20-30 MV FOR MEN CLSC EW STD BLACK V
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257128114·20-30 MV FOR MEN SEL EW CLF STD BLK V
ORTHOFIX
FDA UDI
ORTHOFIX SRL·18059015374452·STANDARD LOCKING SCREW L57.5MM D4.0MM
SSW CARBIDE
FDA UDI
Ss White Burs, Inc.·D6901405752·FG SL CARBIDE 557 - 5 PACK
Sterile ACIF PEEK
FDA UDI
Tyber Medical, LLC·M6958101405750·ACIF - 14mm x 5mm x 7.5 deg PEEK Curved
ORTHOFIX
FDA UDI
ORTHOFIX SRL·18059015373950·STANDARD LOCKING SCREW L57.5MM D4.0MM STERILE
LDR SPINE USA SPINE TUNE TL SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMUFLEX DISPOSABLES
FDA Adverse Event
Malfunction
·TERUMO CORPORATION/TERUMO BCT·Product code CAK·May 31, 2013
AFFINITY BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·June 16, 2011
RESOLUTION CLIP DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MND·August 28, 2008
MICRUSFRAME14 4MM X 8CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·August 30, 2021
PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. 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