15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WINGMAN EXTENDABLE TIP SUPPORT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05707131257499·H15, BTE 13 WL 85 CBE
RC Screw-retained Abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600303299·
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102954·PISACANO NUCLEUS ROTATOR HORIZONTAL
EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN CUP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 9, 2017
MLRY-HD POR FMRL 10X155MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·June 9, 2017
CER OPT TYPE 1 TPR SLEVE 0MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·June 9, 2017
OSCILLATING SAW ATTCHMT/LARGE W/KEY FOR SMALL BATTERY DRIVE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·May 29, 2013
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·June 14, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
DISCARDIT¿ II SYRINGE W/O NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 7, 2017
20ML DISCARDIT¿ II SYRINGE W/O NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 4, 2017
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021