8 results · 21ms · Sources: EU EUDAMED, US FDA

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DormoTech NLab

FDA 510(k)
FDA Class 2 ·Anesthesiology

KangLi pedical screw spinal system

FDA 510(k)
FDA Class 2 ·Orthopedic

VACUUM ASSISTED CORE BIOPSY DEVICE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

VERSATAP SUTURE ANCHOR

FDA Adverse Event
Malfunction ·ORTHO-DESIGN·Product code MBI·September 15, 2025

FENESTRATED BIPOLAR FORCEPS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·November 11, 2014

ACCESS® FREE T4 CALIBRATORS

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code CEC·September 10, 2011

UNIVERSAL STEM 115X18MM FLUTED

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 23, 2013

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID, REF 144-28-08; e. 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID, REF 144-28-09; f. 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID, REF 144-28-10; g. 0 DEG MCS CONSTRAINED LINER 50-52 MM, 28 MM ID, REF 146-28-04; h. 0 DEG MCS CONSTRAINED LINER 54-58 MM, 28 MM ID, REF 146-28-05; i. 0 DEG MCS CONSTRAINED LINER 60-64 MM, 32MM ID, REF 146-32-06; j. O DEG ACUMATCH CONSTRAINED LINER SZ E 32MM ID, REF 144-32-05; k. O DEG ACUMATCH CONSTRAINED LINER SZ F 32MM ID, REF 144-32-06; l. O DEG ACUMATCH CONSTRAINED LINER SZ G 32MM ID, REF 144-32-07; m. O DEG ACUMATCH CONSTRAINED LINER SZ H 32MM ID, REF 144-32-08; n. O DEG ACUMATCH CONSTRAINED LINER SZ J 32MM ID, REF 144-32-09; o. O DEG ACUMATCH CONSTRAINED LINER SZ K 32MM ID, REF 144-32-10;

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022