20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELECTROPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ACUFEX
FDA UDI
Smith & Nephew, Inc.·03596010080875·RASP COMPOUND CURVE
Lumbar Interbody Fusion System (OLLIF)
FDA UDI
ADVANCED RESEARCH MEDICAL LLC·00850014575007·Lumbar Interbody Fusion System (OLLIF) Oblique ...
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482050682·Symmetry® Knife Handle, #7, 9 in, 228 mm
STEVE MADDEN
FDA UDI
FGX INTERNATIONAL INC.·00193033440520·
Mtira
FDA UDI
Kalitec Direct LLC·B07307K0157080·Trial Drill Guide Tube, 8mm
B-D NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON CO.·Product code FMI·January 10, 2001
REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTD·September 12, 2019
APPLICATOR TIP/DUAL SPRAYER KIT
FDA 510(k)
FDA Class 2
·General Hospital
KAVO CORUND HANDPIECE 2013
FDA 510(k)
FDA Class 2
·Dental
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962107027·KNIFE HANDLE, 9", #8
NCB®, SCREW, SELF-TAPPING, ø 4.0 MM, 32 MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·February 6, 2026
NCB®, SCREW, SELF-TAPPING, ø 4.0 MM, 30 MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·February 6, 2026
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 14, 2024
ARTIC FRONT ADVANCE
FDA Adverse Event
Malfunction
·MEDTRONIC, INC·Product code DQY·March 12, 2013
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTL LTD·Product code KWA·February 24, 2011
DPS PRESSURE MONITORING KIT W/ ANTI SHUNT
FDA Adverse Event
Malfunction
·SMITHS MEDICAL·Product code DRS·March 12, 2008
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·May 16, 2018
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015