20 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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PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
TOTAL KNEE REPLACEMENT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·November 10, 2016
PATIENT SPECIFIC TOTAL FEMUR
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·August 15, 2018
Holder
FDA UDI
ADLER ORTHO SPA·08050507136933·CONDYLES HOLDER ASSEMBLY FOR UNIVERSAL HANDLE
Chart, X-Ref Puritan Bennett 089069
FDA UDI
A-M SYSTEMS, LLC·00817081025767·Chart, X-Ref Puritan Bennett 089069,1.5 x 1.2, ...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04059993334056·ELVAREX 1/KNEE HIGH/CLOSED TOE/DOTTED 5 CM SILI...
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167521409000·
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319705155·Randall Kidney Stone Forceps 9-1/4" (23.1cm), 1...
Sterile ACIF PEEK
FDA UDI
Tyber Medical, LLC·M6958101409000·ACIF o 14mm x 9mm x O deg PEEK Curved
MOTIVATION KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
DUAL PORT SPATULA SET, MICRO
FDA UDI
The Wells Johnson Company·B458201409000·Cannula Set, Dual Port Spatula, Micro, contains...
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 22, 2024
EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code KWT·October 6, 2022
ALIGN TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code FTL·May 24, 2013
SCREW,FIXATION,BONE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HWC·October 3, 2014
NELLCOR EASY CAP II
FDA Adverse Event
Death
·COVIDIEN/ FORMERLY TYCO·Product code CCK·June 17, 2011
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indications, is maintained for each device, which may be used independently and at different times. These specific kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that were recalled as part of RES 98317 with (510(k): K140100).
FDA Enforcement
Class I
·Ongoing·North American Rescue LLC.·May 6, 2026
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indications, is maintained for each device, which may be used independently and at different times. These specific kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that were recalled as part of RES 98317 with (510(k): K140100).
FDA Recall
Open, Classified
·North American Rescue LLC.·Product code LRR·March 27, 2026
Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·September 26, 2012