20 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LIGHT CURE FILLING MATERIAL
FDA 510(k)
FDA Class 2
·Dental
MINI OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K85055231·MINI OVATION® Base Rx 022 UL/5-5 CS HK
MINI OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K85055241·MINI OVATION® Base Rx 022 UL/5-5 CS-BC MHK
Zimmer® Segmental System
FDA UDI
Zimmer, Inc.·00889024198708·
ACE Electrosurgical Resection and Vaporization Electrodes Series
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ORTHODONTIC POLYMER COMPOSITE BRACKET
FDA 510(k)
FDA Class 2
·Dental
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523109975·Reduction Polyaxial Screw 8.5mm diameter 55mm l...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523110872·Reduction Cannulated Polyaxial Screw 8.5mm dia...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523108251·Polyaxial Screw 8.5mm diameter 55mm length for ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523108671·Polyaxial Screw 8.5mm diameter 55mm length for ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523110421·Cannulated Polyaxial Screw 8.5mm diameter 55mm...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523111329·Cannulated Polyaxial Screw 8.5mm diameter 55mm...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523109098·Reduction Polyaxial Screw 8.5mm diameter 55mm l...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523111770·Reduction Cannulated Polyaxial Screw 8.5mm dia...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523109524·Polyaxial Screw 8.5mm diameter 55mm length for ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523107438·Polyaxial Screw 8.5mm diameter 55mm length for ...
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·August 14, 2012
ST104 TRANSPORT
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIV.·Product code FPO·September 21, 2010
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