17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Technoweb Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704511086·
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780361008·Integra® Miltex® Adson Tissue Forceps, 4-3/4", ...
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100813·FLIERINGA FIXATION RING 20MM
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702463347·Elvarex 3/Thigh High/Slant, Closed Toe, E-Versi...
Lacrimal Probe
FDA UDI
KATENA PRODUCTS, INC.·00841668108734·BOWMAN LACRIMAL PROBE SET OF 6
SENTINEL
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522123207·SENTINEL 10 TEST SYSTEM, RDT
ONE STEP HCG URINE/SERUM TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICRO ADSON TISS FCPS 1X2
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC.·Product code GEN·June 5, 2019
COOLSCULPTING SYSTEM
FDA Adverse Event
Injury
·ALLERGAN PLEASANTON·Product code OOK·September 3, 2021
OMNIPOD INSULIN PUMP
FDA Adverse Event
INSULET CORPORATION·Product code LZG·January 6, 2009
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 17, 2013
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code MMI·July 22, 2011
CONTOUR CURVED CUTTER STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·September 22, 2008
VITEK MASS SPECTROMETER
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code PEX·October 12, 2017
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