17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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