22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM
FDA 510(k)
FDA Class 2
·Orthopedic
Dark Star Deformity
FDA UDI
Republic Spine, LLC·B0751002380·Torque Limiting Inline-Handle
METZENBAUM SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896046764·METZENBAUM SCISSORS STRAIGHT BLADE
GEN4 DIGITAL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828113328·GEN4 DIGITAL
Bump-R-Sleeve Tubing
FDA UDI
TP ORTHODONTICS INC·00192029039014·Grey
Tether™
FDA UDI
Seaspine Orthopedics Corporation·10889981035495·Plate - 2 Level - 38mm
MOBILE LINER DIA.INT.28MM DIA.EXT.40MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LZO·July 10, 2023
ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+
FDA 510(k)
FDA Class 2
·General Hospital
HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
FDA 510(k)
FDA Class 2
·Microbiology
PHYSICA KR TIB. LINER RIGHT #5
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code MBH·May 2, 2024
OXYGENATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 15, 2015
CMD 25-1435 PROMADE SHOULDER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code PHX·May 18, 2026
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 8, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 18, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 16, 2011
SMR HUMERAL HEAD Ø48 MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWT·May 8, 2024
CARTO 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·December 14, 2023
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·October 5, 2022
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·February 26, 2014
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
FDA Enforcement
Class II
·Ongoing·Genesee BioMedical, Inc.·June 6, 2018