390 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BioUniversal PKF
FDA UDI
IVOCLAR VIVADENT, INC.·D7075773500·BioUniversal PKF 25 g
BioUniversal PKF
FDA UDI
IVOCLAR VIVADENT, INC.·D7075841520·
BioUniversal PKF
FDA UDI
IVOCLAR VIVADENT, INC.·D7075798740·BioUniversal PKF 5 g
BioUniversal PKF
FDA UDI
IVOCLAR VIVADENT, INC.·D7075773510·BioUniversal PKF 100 g
BioUniversal PKF
FDA UDI
IVOCLAR VIVADENT, INC.·D7075798760·BioUniversal PKF 1oz/31 g
BIOUNIVERSAL PKF
FDA 510(k)
FDA Class 2
·Dental
Universal Solder PKF
FDA UDI
IVOCLAR VIVADENT, INC.·D7075733730·Universal Solder PKF
MICRO/MINI N-PK(F) BONE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
C&B PROSTHETIC KIT
FDA UDI
OCO BIOMEDICAL INC·D78550ICBPKF0·5.0MM ISI CROWN & BRIDGE PROSTHETIC KIT
ISI C&B PROSTHETIC KIT
FDA UDI
OCO BIOMEDICAL INC·D78540ICBPKF0·4.0MM ISI CROWN AND BRIDGE PROSTHETIC KIT
CARDINAL HEALTH
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code PKF·July 20, 2023
NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8229738, 8MM ID 3 PK
FDA Recall
Open, Classified
·Medtronic Xomed, Inc.·Product code ETN·November 7, 2023
NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8229738, 8MM ID 3 PK
FDA Enforcement
Class II
·Ongoing·Medtronic Xomed, Inc.·January 17, 2024
Cardinal Health Custom Sterile Latex Free Convenience Kits; sterile single use disposable devices packaged in plastic pouches; Cardinal Health, McGaw Park, IL 60085 U.S.A.; identified by the following catalog numbers: a) Cat. POOCOTFGB - Sterile Ortho Pack b) Cat.SOP22ARCLC - Sterile Arthoscopy Pack c) Cat. SOP30ARCOB - Sterile Knee Arthroscopy Pack d) Cat. SOP30ARCOC - Sterile Knee Arthroscopy Pack e) Cat. SOP30ARKGC - Sterile Arthroscopy Pk f) Cat. SOP30ARMCB - Sterile McCallum Surgical Pack g) Cat. SOP30ARNOA - Sterile Arthroscopy Pack h) Cat. SOP30KANRA - Sterile Knee Arthroscopy Pack i) Cat. SOP30LENHC - Strl Major Lower Extremity Pk j) Cat. SOP30SADTE - Strl Shoulder Arthroscopy Pack k) Cat. SOP30THDTD - Sterile Total Hip Pack l) Cat. SOP30THNOA - Sterile Total Hip Pk m) Cat. SOP30THSJA - Sterile Total Hip Pack n) Cat. SOP30TKSJA - Sterile Total Knee Pack o) Cat. SOP30THVCH - Sterile Total Hip Pack p) Cat. SOP30TKVCE - Sterile Total Knee Pack
FDA Recall
Terminated
·Cardinal Health·Product code LRO·October 3, 2005
Medical convenience kits IHDC30R D AND C PACK
FDA Recall
Open, Classified
·American Contract Systems Inc.·Product code PKF·September 4, 2025
D&C pack
FDA Recall
Open, Classified
·American Contract Systems, Inc.·Product code PKF·June 16, 2022
D And C Tray
FDA classification
FDA Not Classified
·D And C Tray
EKF Life Sciences
FDA registration
EKF Life Sciences·3 products·🇺🇸 United States
EKF DIAGNOSTIC GMBH
FDA registration
EKF DIAGNOSTIC GMBH·4 products·🇩🇪 Germany
MILTA PKP-GIT
FDA registration
MILTA PKP-GIT·3 products·🇷🇺 Russian Federation