15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT
FDA 510(k)
FDA Class 2
·Orthopedic
Measuring Device
FDA UDI
ADLER ORTHO SPA·08050507139323·SICKLE-SHAPED MEASURING DEVICE
SimPro™ Now
FDA UDI
Wellspect AB·07392532188275·Single Use Urinary Catheter with water sachet. ...
GRAEFE IRIS FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896073333·GRAEFE IRIS FORCEPS STRAIGHT TIPS TITANIUM
SureCore Semi-automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414641400·Semi-automatic Disposable Biopsy Needle
SureCore Semi-automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414641615·Semi-automatic Disposable Biopsy Needle
SureCore Semi-automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414641530·Semi-automatic Disposable Biopsy Needle
QWIKCHECK-BEADS
FDA 510(k)
FDA Class 2
·Hematology
INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL
FDA 510(k)
FDA Class 2
·Cardiovascular
UNK COOLSCULPTING
FDA Adverse Event
Injury
·ALLERGAN PLEASANTON·Product code OOK·September 12, 2022
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
X8000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·May 31, 2011
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021