22 results · 22ms · Sources: EU EUDAMED, 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