21 results
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38ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)
FDA 510(k)
FDA Class 2
·Orthopedic
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776187521·MAYO COON DUCT SCOOP . MALLEABLE SHAFT, MEDIUM
QCT Pro Asynchronous Calibration Module, CliniQCT
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DIASYNC0·The QCT Pro Asynchronous Calibration Module is ...
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981208844·Trial, 11mm x 40mm x 14mm, 20 deg
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319704592·Rochester (Pean) Hemostatic Forceps 8" (20cm), ...
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981201722·Interbody, 11mm x 40mm x 14mm, 20 deg
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981193737·Interbody, 11mm x 40mm x 14mm, 20 deg
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197051095·Bengolea Hemostatic Forceps
1x2 te...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197540223·Caspar Rongeur upwards angled 2x12mm 140
mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197051101·Bengolea Hemostatic Forceps
1x2 te...
BD Q-SYTE LUER ACCESS SPLIT SEPTUM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·June 22, 2022
AEQUALIS REVERSED SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE
FDA 510(k)
FDA Class 2
·Radiology
K-WIRE
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HWC·December 9, 2016
EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code KWT·October 6, 2022
MESHGRAFT II COMPLETE
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code FZW·May 29, 2013
IDENTITY ADX DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 13, 2014
COLLEAGUE PRE-P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 25, 2011
MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS) Skeletal system: Bone studies. Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement. Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·April 3, 2019
Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·April 3, 2019