31 results · 25ms · Sources: EU EUDAMED, US FDA

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091 Balloon Guide Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

N/A

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994203663·CASE 7220331 SCREW PREP TRAY

ELMED

FDA UDI
ELMED INCORPORATED·00842180170568·3 MM DIA., 29 CM BEHRMAN NEEDLE & PROBE

SYNGO CT DYNAMIC ANGIO

FDA 510(k)
FDA Class 2 ·Radiology

PASCO MIC AND MIC/ID PANELS

FDA 510(k)
FDA Class 2 ·Microbiology

OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·June 19, 2024

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Death ·CORDIS DE MEXICO·Product code NIQ·November 4, 2008

MINICAP TRANSFER SET

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 23, 2011

DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

STEALTHSTATION¿ S8 SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 23, 2026

Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368

FDA Recall
Terminated ·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code LZO·February 28, 2018

Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368

FDA Enforcement
Class II ·Terminated·Zimmer GmbH·May 2, 2018

LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL

FDA Enforcement
Class II ·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022

BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

FDA Enforcement
Class II ·Terminated·Bard Peripheral Vascular Inc·January 1, 2020

SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT

FDA Enforcement
Class II ·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022

SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT

FDA Enforcement
Class II ·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022

LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP

FDA Enforcement
Class II ·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022

LUMBAR PUNCTURE TRAY ADULT 18G X 3.5

FDA Enforcement
Class II ·Ongoing·Bard Peripheral Vascular Inc·March 23, 2022

Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

FDA Enforcement
Class I ·Terminated·TELEFLEX MEDICAL INC·February 23, 2022

Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.

FDA Enforcement
Class II ·Terminated·Zimmer Dental Inc·April 4, 2018