20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IRRIGATION OR INFUSION PUMP K PUMP
FDA 510(k)
FDA Class 2
·General Hospital
MODEL SE-1 EYEGLASS HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SCISSORS: THOREK, JORGENSEN, FINOCHIETTO
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CONSULT HCG TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025
CATGUT CHROMIC 2/0 (3.5) 100M
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL SA·Product code GAL·November 27, 2018
CATGUT CHROMIC 3 (7) 50M
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL SA·Product code GAL·November 20, 2018
PINNACLE 100 HA ACET CUP 58MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·March 6, 2013
SUMMIT POR TAPER SZ4 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 8, 2014
SPRINT QUATTRO
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011
CATGUT PLAIN 3/0 (3) 100M
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAL·May 28, 2020
CATGUT PLAIN 1 (5) 75M
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAL·July 20, 2020
CATGUT PLAIN 1 (5) 75M
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAL·February 10, 2021
CATGUT CHROMIC 2 (6) 50M
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAL·February 25, 2021
ACIST
FDA Adverse Event
Malfunction
·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·April 20, 2007
MEDIUM CHROM CAT 3/0 (3) 100M BAYER EE
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAL·February 17, 2020
CATGUT PLAIN 6 (10) 25M D2
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAL·December 31, 2019
CATGUT PLAIN 5 (9) 25M
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAL·July 16, 2019
CATGUT PLAIN 5 (9) 25M
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAL·October 29, 2019
CATGUT PLAIN 5 (9) 25M
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAL·December 31, 2019
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024