20 results · 22ms · Sources: EU EUDAMED, 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