15 results · 23ms · Sources: EU EUDAMED, 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