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