13 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EDENTA
FDA UDI
EDENTA ETABLISSEMENT·E312K90044610001·Dowel Pin 12 mm
ABC CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ASTHMA MONITOR MODEL, AM1
FDA 510(k)
FDA Class 2
·Anesthesiology
ACCESS
FDA Adverse Event
Malfunction
·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code BRZ·June 27, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 7, 2013
INTERSTIM
FDA Adverse Event
Malfunction
·MILACA·Product code LGW·October 28, 2010
Catalog Number: 900486 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OHD·January 7, 2016
Catalog Number: 900486 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class II
·Terminated·Customed, Inc·April 20, 2016
Laparoscopy Pack, Catalog number 900-486. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code FDE·October 8, 2014
Laparoscopy Pack, Catalog number 900-486. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
LAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
LAPAROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE % ECONOMY 53" X 77" LIF (1) TUBE SUCTION CONNECT. v.i" X 12' LIF (1) SCALPEL WITH HANDLE #11 (1) DRAPE LAP ABDOMINAL WITH POUCH 1 02" X 122" X 78" LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (8) TOWEL ABSORBENT 15" X 20" L/F (1) TABLE COVER REINFORCED 50" X 90" L/F (1) *LAPAROSCOPIC WOUND CLOSURE LATEX (1) DRAPE LASER CAMERA WITH/EL 6" X 96" LIF (4) DRAPE UTILITY WITH TAPE L/F (3) GOWN IMPERVIOUS REINFORCED X-LARGE SMS L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014