21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DR COMFORT
FDA UDI
DJO, LLC·00888912235594·Sheer ThighHs OT W 20-30 BLK S
Young
FDA UDI
YOUNG DENTAL MANUFACTURING I, LLC·00302731323121·Young DPA Classic Turbo, Firm, Long, White Turb...
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102381·GIMBEL NUCLEUS SPATULA 0.25MM
ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
THERATRODE
FDA 510(k)
FDA Class 2
·Neurology
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101122·L CR E-MAXTM Vitamin E Ultracongruent Tibial In...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523164455·L Ultracongruent Tibial Insert Trial with Anter...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523144617·L CR UHMWPE Ultracongruent Tibial Insert Sz B 12mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101986·L CR MAXTM HXL Ultracongruent Tibial Insert Sz ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523124206·L Ultracongruent Tibial Insert Trial Sz B 12mm
TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code PAH·October 8, 2018
BD ULTRA-FINE II INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·July 27, 2021
ZELTIQ COOLCORE (6.3)
FDA Adverse Event
Injury
·ZELTIQ AESTHETICS INC.·Product code OOK·June 19, 2014
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code KRG·October 1, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
CASTVAC W/8 FOOT HOSE AND MOBILE STAND
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code LGH·June 11, 2011
XVWEB
FDA Adverse Event
Injury
·PLANET DDS·Product code LLZ·March 13, 2025
SECOND OPINION
FDA Adverse Event
Injury
·PEARL INC.·Product code MYN·March 13, 2025
ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Skeletal Kinetics, Llc·July 22, 2020