11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENEMA KIT 'STRAIGHT' DESIGN
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
N/A
FDA UDI
Smith & Nephew, Inc.·00885556601068·MTO BSKT PCH DUCKLING UPBITER
...
TDK HANDPIECES
FDA 510(k)
FDA Class 1
·Dental
PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM
FDA 510(k)
FDA Class 2
·General Hospital
INTERSTIM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code EZW·June 27, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 17, 2010
WECK HEMOLOK TAKEAPART XL 10MM ENDO APPLIER
FDA Adverse Event
Malfunction
·TELEFLEX·Product code FZP·December 12, 2012
Laparotomy Pack, Catalog # 900-848 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 # 900-848 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
LAPAROTOMY PACK CS/6 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
LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (2) DRAPE SHEET 41 II X 58" SMS L/F ( 1) TABLE COVER 50" X 90" LIF ( 1) SOLUTION SURGICAL DURAPREP 26ML LIF (1) BLADE SURGICAL# 10 CARBON STEEL (5) LAP SPONGE PREWASH 18" X 18' XRD LIF (6) TOWELS ABSORBENT 15" X 20" LIF ( 1) CAUTERY TIP POLISHER L/F (2) UTILITY BOWL 16oz LIF (1) TUBE SUCTION CONNECT%" X 12' LIF (2) NEEDLE & BLADE COUNTER 10c MAG /CLEAR LIF (1) DRAPE T LAPAROTOMY 102" X 78" 121" SMS STD LIF ( 1) SPECIMEN CONTAINER 4oz WITH LID & LABEL ( 1) YANKAUER SUCTION TUBE WITHOUT VENT LIF ( 1) TIME OUT BEACON NON WOVEN LIF ( 1) GOWN SURG. REINFORCED XLGE TOWEL & WRAP 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