16 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sklar
FDA UDI
SKLAR CORPORATION·10649111452000·PENNINGTON CLAMP STR 12 IN
MP Reconstruction Prosthesis
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575270545·Neck Segment,with collar
MP Reconstruction Prosthesis
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575270538·Neck Segment,with collar
CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET
FDA 510(k)
FDA Class 2
·Radiology
LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE
FDA 510(k)
FDA Class 2
·Orthopedic
SELUTE PICOTIP
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·July 23, 2011
CURLIN INFUSION IV PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICE GROUP·Product code FRN·May 30, 2013
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 25, 2008
ELAN 4 MIS SLEEVE F/1-RING HANDPIECES
FDA Adverse Event
Injury
·AESCULAP AG·Product code HBC·October 28, 2018
BIOMET MODULAR TIBIAL LOCKING BAR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·February 9, 2018
E1 VANGUARD TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·February 9, 2018
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DYB·June 27, 2024
ELAN 4 ELECTRO MOTOR CABLE W/HAND SWITCHHIGH SPEED POWER SYSTEMS
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code HBC·November 5, 2018
MICROPUNCTURE TRANSITIONLESS ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·March 29, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022