17 results · 23ms · Sources: EU EUDAMED, US FDA

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Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

LCP

FDA UDI
Synthes GmbH·10886982167057·3.5MM LCP® ANTEROLATERAL DISTAL TIBIA PL 7 HOLE...

Broach 44 size 3

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215055448·

INFRONT LUMBAR INTERBODY FUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Injury ·DEXCOM, INC.·Product code QBJ·May 12, 2026

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 9, 2011

SERVO VENTILATOR 300A

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·September 26, 2008

ENDOTAK RELIANCE

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVY·July 22, 2013

TPRLC 133 FP TYPE1 PPS SO 4.0

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code KWY·June 10, 2019

TPRLC 133 FP TYPE1 PPS SO 8.0

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code KWY·June 7, 2019

TPRLC 133 T1 PPS SO 18X156MM

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code KWY·June 7, 2019

TPRLC 133 T1 PPS SO 17X154MM

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code KWY·June 7, 2019

TPRLC 133 T1 PPS HO 16X152MM

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code KWY·June 7, 2019

TPRLC 133 FP TYPE1 PPS SO 6.0

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code KWY·June 10, 2019

TPRLC 133 T1 PPS SO 15X150MM

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code KWY·June 7, 2019

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60

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