16 results · 21ms · Sources: EU EUDAMED, US FDA

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PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL

FDA 510(k)
FDA Class 2 ·Dental

XLIF

FDA UDI
Nuvasive, Inc.·00887517055538·NAV.S XLIF Trial, 8x18mm 10° Lollipop

XLIF

FDA UDI
Nuvasive, Inc.·00195377026392·XLIF AMS Trial, 8x18mm 10° Lollipop

XLIF

FDA UDI
Nuvasive, Inc.·00887517053763·XLIF AMS Trial, 8x18mm 10° Modular

Sof-Flex

FDA UDI
COOK INCORPORATED·00827002150256·Sof-Flex Loop Suprapubic Catheter Set

General Instrument

FDA UDI
ALPHATEC SPINE, INC.·00840180505069·PLIF/TLIF Endplate Scraper, Straight, 12mm

URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING

FDA 510(k)
FDA Class 2 ·Orthopedic

AVISTA MRI

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 19, 2024

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013

ACCU-CHEK FLEXLINK PLUS

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FRN·April 13, 2011

FLANGE FIXTURE AND ABUTMENT

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS, AB·Product code LXB·July 25, 2008

CANNULA & CATHETER

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DWF·April 22, 2025

Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience custom kits used for general surgery in hospital operating room

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015