25 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NAVIO
FDA 510(k)
FDA Class 2
·Neurology
SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
FDA 510(k)
FDA Class 2
·Ophthalmic
VALLEYLAB SUCTION COAGULATOR, MODEL E3305
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·February 2, 2021
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
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·August 4, 2011
AML 12.0 MMA 6.3 5/8 STD 12/14
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 26, 2013
OXIMAX N-595 PULSE OXIMETER
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DQA·September 26, 2008
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
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
BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·April 22, 2020
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
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020