17 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MyKnee PPS-Pin Positioners
FDA 510(k)
FDA Class 2
·Orthopedic
MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK - RIGHT - #6
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2018
MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK SPHERE- LEFT - SIZE6+
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2018
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776164409·Van Buren Cath Guide fr
LINK Instruments - Chisel, bone curette, raspatory, rongeur
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575235711·Orthopaedic prosthesis instrument, reusable - G...
VV FLUORO 3D
FDA 510(k)
FDA Class 2
·Neurology
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE
FDA 510(k)
FDA Class 2
·Microbiology
VIDAS® TPSA
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code MTF·July 20, 2016
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·October 16, 2017
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·June 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·October 14, 2014
INTEGRA MESHED BILAYER WOUND MATRIX SIZE 8X10
FDA Adverse Event
Other
·INTEGRA, PLAINSBORO·Product code GXQ·June 20, 2011
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 14, 2016
EUFLEXXA
FDA Adverse Event
Injury
·BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.·Product code MOZ·July 9, 2012
OT VERIO IQ METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 10, 2013
MAGNETOM Skyra fit. Model Number: 10849580.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack AMS12341B Hassan Pack AMS12343A Meldrum Pack AMS12359B Neuro Pack AMS12520 Total Hip Pack AMS12608 Extremity Pack AMS12610 Shoulder Pack AMS12636 Dr. Thompson Pack AMS12689A Custom Pack AMS12753 Breast Pack AMS12754 Abdominoplasty Pack AMS12769 Minor Pack AMS12926 Shoulder Pack AMS12927 Retina Pack AMS13428 Hand Pack AMS2120D Plastics Tray AMS2890(B Basic Biopsy Tray AMS3824(A Myelogram Tray - RX AMS4022F Lami Pack AMS4371C Lasik Eye Pack AMS4372 Plastic Eye Pack AMS4599(C Spine Pack AMS4670B Upper Extremity Pack AMS4766C Shoulder Arthroscopy Pack AMS4952A Vitrectomy Pack - RX AMS5697A EVLT Pack AMS5819B Ortho Major Pack AMS5887A CARS Pack AMS6112A Minor Extremity Pack AMS6112B Minor Extremity Pack AMS6160C Hip Pack AMS6277A Procurement Bundle - Pack A/B/C AMS6728A Breast Pack AMS7463B Retrieval Pack AMS7971 TVOR Pack AMS8094 Plastics Eye Pack AMS8664B Spinal Pack AMS8989 Hysteroscopy Pack AMS9118 Retrieval Pack AMS9197 Arthroscopy Pack AMS9435 Foot Pack AMS9487A Toy Hip Pack AMS9487B Total Hip Pack CMP1018G Cataract Kit - Dr. Wright PSS1838B Medical Imaging Kit VPP1020A Custom Dental Pack VPP1023B OR Implant Bundle Pack WAL1207C Minor Pack
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·January 11, 2023