20 results · 22ms · Sources: EU EUDAMED, 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