24 results · 22ms · Sources: EU EUDAMED, US FDA

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XSTAT-12, 3-Pack, XSTAT-12, 1-Pack

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

XENMATRIX

FDA UDI
Davol Inc.·00801741031397·XenMatrix Surgical Graft, 10 cm x 20 cm (3.9” x...

OSS™ Orthopedic Salvage System

FDA UDI
Biomet Orthopedics, LLC·00880304250857·

OsteoMed

FDA UDI
OSTEOMED LLC·00845694032216·2.0mm  Cannulated Drill, Fusion, Quick Release

MEGA SPINE SYSTEM

FDA UDI
BK MEDITECH CO.,LTD.·08809763500732·Mono Screw Driver

Symmetry Rochester-Pean

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482040256·Symmetry® Forceps, Rochester-Pean Hemostatic, S...

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16720031610200·

Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY

FDA Enforcement
Class II ·Terminated·Terumo Medical Corp·December 20, 2017

OsteoMed

FDA UDI
OSTEOMED LLC·00845694068345·HPS 2.0 Fusion 2mm Drill Quick Release Sterile ...

DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ATRICURE DISSECTOR

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

ACCESS 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 17, 2011

CARELINK

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code KRG·October 10, 2014

BELLAFILL DERMAL FILLER

FDA Adverse Event
Injury ·SUNEVA MEDICAL, INC.·Product code LMH·January 6, 2017

BIODESIGN OTOLOGIC REPAIR GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH·Product code KHJ·September 19, 2018

BIODESIGN OTOLOGIC REPAIR GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH·Product code KHJ·March 8, 2021

BIODESIGN OTOLOGIC REPAIR GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH·Product code KHJ·January 11, 2018

GRACE MEDICAL, INC. NOTCHED TITANIUM BUCKET HANDLE

FDA Adverse Event
Injury ·GRACE MEDICAL, INC.·Product code ETB·July 3, 2019

BIODESIGN OTOLOGIC REPAIR GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH·Product code KHJ·October 14, 2019