21 results · 21ms · Sources: EU EUDAMED, 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