17 results
·
18ms
·
Sources: EU EUDAMED, US FDA
VITEK ANAEROBE IDENTIFICATION CARD
FDA 510(k)
FDA Class 1
·Microbiology
DYONICS
FDA UDI
Smith & Nephew, Inc.·00885554006957·SOD BURR 5.5 TAPERED DSPL (6)
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·10840117400693·
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·00840117408388·
TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND
FDA 510(k)
FDA Class 1
·Dental
PONTO PRO
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·September 4, 2014
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code JDI·September 4, 2014
ATLAS PLUS DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 30, 2014
EYE SURGERY STRETCHER
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code FPO·November 10, 2010
HEARTSTREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 13, 2012
Catalog Number: 900996 LAPAROTOMY 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 LRO·January 7, 2016
Laparotomy Pack, Catalog # 900-996 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 LRO·October 8, 2014
Laparotomy Pack, Catalog # 900-996 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
Catalog Number: 900996 LAPAROTOMY 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
LAPAROTOMY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
LAPAROTOMY PACK- (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGES PRE-WASH 18" X 18" XRD LIF (1) LITE GLOVE LIF (1) BAG SUTURE FLORAL (1) BLADE SURGICAL #1 0 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) CAUTERY TIP POLISHER LIF (1) BAG GLASSINE (1) TABLE COVER 44" X 90" L/F (2) DRAPE SHEET 41 " X 58" SMS (1) LAPAROTOMY DRAPE "T" 102" X 78" X 121" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (1) TUBE SUCTION CONECT W' X 12' LIF (3) ABSORBENT TOWELS 15" X 20" LIF (1) CAUTERY PENCIL PUSH BOTTON (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP LEVEL Ill (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF 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