17 results · 19ms · Sources: EU EUDAMED, US FDA

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MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032390·Baltic Denture System BDLoad Sw6 PLSEbm6DFs A4 ...

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120323901·Diamond, cone round, COOL DIAMANT, coarse grit,...

Ophthalmic Spatula

FDA UDI
KATENA PRODUCTS, INC.·00841668102824·NAGAHARA LENS NUCLEUS SPATULA

B LOCUS HIGH RES SSP UNITRAY KIT WITH TAQ POLY

FDA Adverse Event
Malfunction ·LIFE TECHNOLOGIES CORPORATION·Product code MZI·January 15, 2014

QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H

FDA 510(k)
FDA Class 2 ·Physical Medicine

NO STEP ON SITE DEUG TEST CUP

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

NATURALYTE

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·March 29, 2013

DLT TS CER HD 12/14 28MM + 8.5

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD·Product code LZO·March 28, 2011

PUMP MMT-715LNAS PRDGM INS V2.1 SK EN

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code LZG·April 17, 2008

ACCUVUE ADVANCE

FDA Adverse Event
Injury ·VISTAKON·Product code LPL·October 19, 2007

Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code LNH·October 12, 2005

Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.

FDA Enforcement
Class II ·Terminated·Leica Microsystems, Inc.·December 2, 2015

BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300 Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code ISL·March 1, 2011

The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016