17 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rectangular Corpectomy Cage
FDA 510(k)
FDA Class 2
·Orthopedic
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741524600·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674152460060·
K152468
FDA UDI
Shenzhen Vistar Medical Supplies Co.,Ltd.·96973521874184·Reusable NIBP cuff,Thigh,single tube, HP connector
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704284300·
Low Profile Acetabular Reamer 60
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215057633·
Endo-Model Standard Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575044924·Hinge Knee Joint Prosthesis,with hinge axis
Endo-Model Standard Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575044931·Hinge Knee Joint Prosthesis,with hinge axis
AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH
FDA 510(k)
FDA Class 2
·Anesthesiology
POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE
FDA 510(k)
FDA Class 2
·Radiology
TARGET TIP
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code DTB·June 7, 2013
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH·Product code LWS·July 14, 2014
OXIMAX N-595 PULSE OXIMETER
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code DQA·June 21, 2011
ELAN 4 MIS SLEEVE F/1-RING HANDPIECES
FDA Adverse Event
Injury
·AESCULAP AG·Product code HBC·October 28, 2018
ELAN 4 ELECTRO MOTOR CABLE W/HAND SWITCHHIGH SPEED POWER SYSTEMS
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code HBC·November 5, 2018
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
FDA Enforcement
Class II
·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019
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