10 results · 20ms · Sources: EU EUDAMED, US FDA

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GS & GS20 SURGICAL TOOL SYSTEM

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

BENCO

FDA UDI
BENCO DENTAL SUPPLY CO.·00366975065476·

3M™ Victory Series™

FDA UDI
3M UNITEK CORPORATION·00652221116017·3M™ Victory Series™ First Molar Bands, 952-463,...

BENCO DENTAL

FDA UDI
PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI·00850144008956·BENCO Sterilization Tubing with Indicator 6" RO...

PROMETAL HN86

FDA 510(k)
FDA Class 2 ·Dental

SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant

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

PROPAQ MD DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 14, 2014

ELECTRODE, PACEMAKER, PERMANENT

FDA Adverse Event
Malfunction ·MPRI·Product code DTB·February 9, 2013

COAGUCHEK® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·January 7, 2011

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022