19 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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ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
FDA 510(k)
FDA Class 2
·Hematology
Cure-Thru Clear Cervical Matrices
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783004809·CURE-THRU CMF BOX OF 150 721 CT
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00610141·
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193104331·HA PEEK EVOS Curved, , 14mmx11mmx 30mm , FLAT 6...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70610141·Mini Sprint-Brackets 5-5 Roth .018" 400 Bracket...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07310K0690140·Tray Insert, MIS Lumbar Instrument 3
HI-FLO THERME PNEU 45, WISAP #7083, 7083V
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ELECSYS ANTI-TPO CALCHECK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
E500 VENTILATOR SYSTEM
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS, INC·Product code CBK·July 11, 2016
TI MATRIX TOP LOADING POLYAXIAL HEAD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·April 16, 2013
MAYFIELD TRIAD SKULL CLAMP
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORPORATION·Product code HBL·June 12, 2008
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·April 18, 2011
1.5MM HEX SCREWDRIVER BLADE HEX COUPLING
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·June 16, 2020
ENCOREANYWHERE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 17, 2016
"***UPLIFT TECHNOLOGIES INC.***Bringing quality to life.***Model No.***CA200***Description***Lifting commode chair***Weight Range***80-300+ lb-136+ kg***" Labeling on product: "***1C0101 and K0061014***". A lifting commode chair that is self-powered (non-electric) and provides lifting assistance for those who have reduced mobility due to arthritis, post-operative conditions, degenerative joint disease, Parkinson's disease or other neuromuscular disorders.
FDA Recall
Terminated
·Uplift Technologies Inc.·Product code INN·June 27, 2011
BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·October 30, 2013
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022