27 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ROG KNOTLESS SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
VaPro Plus Pocket
FDA UDI
HOLLISTER INCORPORATED·00610075054053·No Touch Urethral Intermittent Catheter with In...
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506072970·Tissue Forceps 12" W/O Teeth Serr - Charleys
PNEUMOSTOP®
FDA UDI
LSI Solutions, Inc.·00850012846017·PNEUMOSTOP® PLUS DEVICE
Cook
FDA UDI
COOK INCORPORATED·00827002141001·Malleable Tip Filiform
PNEUMOSTOP®
FDA UDI
LSI Solutions, Inc.·00850200006759·PNEUMOSTOP® PLUS DEVICE
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1102000·Tray, 2 inch base
Leva® Anterior Interbody System
FDA UDI
Spine Wave, Inc.·10840642117998·Modular Spacer, 38 mm (W) x 28 mm (L) x 21 mm (...
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
KENSTONE METAL·Product code ITJ·July 20, 2012
SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EXPECT ENDOSCOPIC ASPIRATION NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197527439·Standard surgical forceps, 1x2 teeth, st
raight...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197029933·Metzenbaum Nelson scissor Fig. 1
straig...
PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code KWI·January 25, 2017
Truliant
FDA UDI
Exactech, Inc.·10885862314437·
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 13, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·May 20, 2011
ACCU-CHEK ACTIVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 14, 2008
LIGHT SOURCE "OLYMPUS CLL-V1", LED, 110-230 V
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code NTN·August 2, 2017
INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013