31 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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