16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER*
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950023226·SUCTION YANKAUER COMPLETE HVAC END 11" 28CM *ST...
NA
FDA UDI
Smith & Nephew, Inc.·00885554005899·MTO OBTURATOR CONICAL 6.25MM
PicoMix V
FDA UDI
G21 SRL·08058964724564·Mixing System and Delivery Syringes
Barricade Coil System
FDA UDI
BALT USA LLC·00818053021282·Barricade Coil System (BCS) is intended for the...
Revolution External Plating System
FDA UDI
Metalogix·00854641008129·Nut and Bolt Caddy Tray
CONLIN MOLAR BAND
FDA UDI
Ortho Arch Company Inc·D90990012918·MOLAR BAND CONLIN RX UPPER RIGHT 43
XBraid TT
FDA UDI
RIVERPOINT MEDICAL, LLC·00840277401205·Suture Tape
Elite®
FDA UDI
Ortho Organizers, Inc.·00190707050740·.022/.045 UR6 CV OCBT -14T 0A 14O
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
FDA 510(k)
FDA Class 2
·Cardiovascular
OncoMate MSI Dx Analysis System
FDA 510(k)
FDA Class 2
·Immunology
LINER: MPACT FLAT PE HC LINER 36/ER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 17, 2020
SINGLE EXTENSION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·May 28, 2014
135 DEG LCP DHHS(TM) SIDEPLATE-STD BARREL 4 HOLES
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code KTT·January 7, 2013
TI ARCOFIX PF PLATE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWQ·November 10, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021