25 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
3i Certain
FDA UDI
Preat Corporation·00842092175309·Titanium Scan Body for 3i Certain 3.4mm
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00126411·
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040130254·Spatula Cement 22
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001641·artVeneer life upper anteriors, IL, BL4
Scanlan® SURG-I-BAND® color coding
FDA UDI
SCANLAN INTERNATIONAL INC·00846159001389·Scanlan® SURG-I-BAND® color coding - Narrow, Gr...
CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD
FDA 510(k)
FDA Class 2
·Dental
METASUL HEAD
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LZO·April 3, 2020
OLYMPUS
FDA Adverse Event
Death
·OLYMPUS MEDICLA SYSTEMS CORP·Product code EOQ·February 26, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·February 18, 2011
EDM LUMBAR CATHETER, 24CM, OPEN TIP
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·February 18, 2008
ATELLICA NEPH 630 SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·May 26, 2022
BI-METRIC/X POR NC LAT 9X125
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·February 22, 2012
TIBIA FIXED NON-POROUS LEFT SIZE F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 14, 2021
VELOCITY DELIVERY MICROCATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DQY·April 29, 2024
ATELLICA NEPH 630 SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·December 10, 2021
ATELLICA NEPH 630 SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·February 21, 2022
ELECTRIC DERMATOME HANDPIECE
FDA Adverse Event
Injury
·ZIMMERBIOMET SURGICAL·Product code GFD·September 22, 2015
Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FET·September 25, 2023