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

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LabPro Data Management System

FDA 510(k)
FDA Class 2 ·Microbiology

CoRoent

FDA UDI
Nuvasive, Inc.·00887517628398·CoRoent Ant TLIF Ti, 10x11x40mm 15°

Dornier MedTech

FDA UDI
Dornier MedTech GmbH·04049958003707·Medilas H30 Solvo Holmium Laser with wireless f...

Zodiac

FDA UDI
ALPHATEC SPINE, INC.·00844856002517·PRE CONTOURED CP ROD 5.5 x 5cm NON-BROACHED

Accufit

FDA UDI
Ortho Organizers, Inc.·00190707183929·Accufit Molar Bands Lower Right First Molar 40 1/2

ABSORBENT PAPER POINTS

FDA UDI
DiaDent Group International·08806383556262·"An absorbent paper points is an endodontic pap...

18M - Loggers - 18 Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588015057·18M - Loggers - 18 Metal

FullFocus

FDA 510(k)
FDA Class 2 ·Pathology

Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain

FDA 510(k)
FDA Class 2 ·Anesthesiology

ARIS TRANSOBTURATOR KIT

FDA Adverse Event
Injury ·COLOPLAST A/S·Product code OTN·May 18, 2023

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020

DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·May 23, 2016

NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405

FDA 510(k)
FDA Class 2 ·Physical Medicine

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 27, 2014

SPRINT FIDELIS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 26, 2013

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·November 28, 2023

NuOSS Cancellous Intended for use in dental surgery.

FDA Recall
Terminated ·Collagen Matrix Inc·Product code NPM·August 25, 2015

Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body.

FDA Recall
Terminated ·Incisive Surgical Inc·Product code GDW·March 19, 2015

MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to No.1 the species level of colonies, grown 34 on solid media, of rapidly growing aerobic and facultative anaerobic gram-positive bacteria

FDA Recall
Terminated ·Beckman Coulter, Inc.·Product code JWY·May 14, 2014