16 results · 29ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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