22 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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PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
FDA 510(k)
FDA Unclassified
·Unknown
Bur PM2-70 50K Carb Ø0.5
FDA UDI
Bien-Air Surgery SA·07630055502377·
Accessory box AB03
FDA UDI
PATH medical GmbH·04260223140730·Accessory Set including:
4pcs. 100013 Probe Tip...
Dark Star Deformity
FDA UDI
Republic Spine, LLC·B0751002610·French Rod Bender
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780432500·Integra® Jarit® Metzenbaum Scissors, 7", Curved
Accessory box AB03
FDA UDI
PATH medical GmbH·04260223143380·Accessory Set with Bio-Logic Branding including...
Femoral Peg Drill
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215040949·
ENDOPATH ETS FLEX
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·November 26, 1997
CARDIOMEDICS ECP SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG
FDA 510(k)
FDA Class 2
·Microbiology
microTargeting™ Electrode Sterilization Tray
FDA UDI
FHC, INC.·00873263002612·microTargeting Electrode Sterilization Tray
BD VACUTAINER K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 20, 2021
LINER: VERSAFITCUP DM 01.26.2854MHC DOUBLE MOBILITY HC LINER Ø 54/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·April 29, 2022
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 26, 2026
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON SARL A JOHNSON & JOHNSON COMPANY·Product code OTN·May 8, 2013
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·September 18, 2014
PULSE GEN MODEL 102
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 16, 2011
PIRANHA
FDA Adverse Event
Malfunction
·RICHARD WOLF GMBH·Product code JCX·July 27, 2021
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·October 5, 2022
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020