20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123090·K-WIRE - DOUBLE TROCAR 1.2mm DIA x 75mm
KODAK LANEX MED. SCREEN
FDA 510(k)
FDA Class 1
·Radiology
HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 7, 2013
MAXIMO VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·August 8, 2014
CAPSURE SENSE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
CATGUT PLAIN 3/0 (3) 100M
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAL·May 28, 2020
ENDO CATCH GOLD
FDA Adverse Event
Injury
·DAVIS & GECK CARIBE LTD·Product code GCI·June 11, 2018
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
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
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022