21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF
FDA 510(k)
FDA Class 2
·Cardiovascular
Epredia
FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693222204·Tissue Marking Dyes are intended as an aid in t...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776187354·NEW ORLEANS NEEDLE HOLDER
Innervision
FDA UDI
MEDTRONIC PS MEDICAL, INC.·00613994908483·KIT 2120-125 INNER/ENDO SHUNT PLCMT REG
STILLE Micro Scissors
FDA UDI
Stille AB·07332339210168·STILLE MICRO VASCULAR SCISSORS, SUPERCUT, Angle...
PMT® CORPORATION HALO
FDA UDI
PMT CORPORATION·00650551044819·DISPOSABLE TORQUE DRIVER
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319703373·Adson-DeBakey Dressing Forceps 4-3/4" (11.9cm),...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780179993·Integra® Jarit® New Orleans Needle Holder, 7"
DIRECTINJECT ON DEMAND HA CEMENT
FDA Adverse Event
Injury
·STRYKER LEIBINGER FREIBURG·Product code GXP·November 24, 2021
VISION SCIENCES FLEXIBLE ENT SCOPE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS
FDA 510(k)
FDA Class 2
·Orthopedic
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197192637·Ferreira Style Breast Retractor
120x25...
SYRINGE 30ML LL S/C 56
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·August 13, 2025
AMPLATZER TORQVUE DELIVERY SYSTEM
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code DQY·July 3, 2012
12/14 ARTICUL 40MM M SPEC+12
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 20, 2013
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·June 3, 2011
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
FDA Enforcement
Class II
·Ongoing·Auris Health, Inc·February 25, 2026
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·October 16, 2024
dS Breast 16ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024