57 results
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29ms
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Sources: EU EUDAMED, US FDA
LAPAROSCOPY PACK CONTENTS: ( I ) BULB SYRINGE 60cc LIF ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) MAYO STAND COYER REINFORCED LIF ( I ) TABLE COVER REINFORCED 50" X 90" LIF (3) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL I V (4) TOWEL ABSORBENT I 5" X 20" LIF ( I ) DRAPE VIDEO CAMERA I 3cm X 244cm LIF (3) LITE G LOVE LIF ( I ) DRAPE LAP ABDOM. WI POUCH 102" X 122" X 78" ( I ) BLADE SURG ICA L # II STAIN LESS STEEL ( I) SYRINGE I Occ W ITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE LIF ( I ) SUTURE BAG FLORAL (I) NEEDLE & BLADE COUNTER I OC MAG I C LEAR L/1' ( I ) CABLE LAP. IOFR 4MM MALE MONOP. LIF (2) DRESSING NON ADH TELfoA 4 X 3 ( I ) SPECIMEN CONTAINER 4oz WITH LID & LABEL (2) SH EET 'll.o 60" X 77" DRAPE R EI NFORCED LIF ( I ) TUBING INSUFFLAT SET WIO RING ADAPTOR LIF ( I ) CI-I LORAPREP 26ML APPLICATOR TEAL LIF ( I ) WRAPPER 24" X 24" (2) DENTURE CUP 8oz WILID ADHERED OUTSIDE OF THE PACK INTO A POUCH: ( I ) NEEDLE ULTRA VERES 1 20MM LIF ( I ) TROCAR ENDO.XCEL DILATING TIP IIM M (D IILT) ( I ) TROCA R ENDO.XCEL DILATING TIP LIF (K5LT) ( I ) CANNU LA 5MM XCEL SLEEVES LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code FDE·May 20, 2014
Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KNEE DOMED PATELLA 522001900 I/B II KNEE DOMED PATELLA for use in total knee arthroplasty
FDA Recall
Terminated
·Product code JWH·January 11, 2016
I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·October 11, 2013
Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee arthroplasty
FDA Recall
Terminated
·Product code JWH·January 11, 2016
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code FRC·April 22, 2013
Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code IXR·October 21, 2004
MultiDiagnost MD4
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
LithoDiagnost
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
Diagnost 96/97 DSI
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
UroDiagnost
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
MultiDiagnost MD3
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
EasyDiagnost
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
Easy Diagnost Digital
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
OmniDiagnost
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
Diagnost 76
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121C, 132C, 134C and 135C steam sterilization cycles. The AccuFast BI is a self-contained biological indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation, the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam, distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization.
FDA Recall
Terminated
·Getinge USA Inc·Product code FRC·August 2, 2013
Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA
FDA Recall
Terminated
·Baxter Healthcare Renal Div·Product code FII·February 20, 2004
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
FDA Recall
Terminated
·Natus Medical Incorporated·Product code LBI·November 19, 2014
Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M1224963, M1225773, M1225066, M1224960, M1225059, M1225023, M1225060, M1225063, M1225064, M1225024, M1231622, M1236303, M1238489, M1238490, M1238492, M1238493, M1238495, M1238499, M1238503, M1238505, M1238507, M1238508, 2063860-001, 2063862-001, 2063870-001, 2063873-001, 2063874-001, 2071393-001, 2080916-001, 2089424-001
FDA Recall
Terminated
·Lumitex Inc·Product code LBI·December 11, 2019
inLight Medical LED Pads used with Polychromatic light technology system
FDA Recall
Terminated
·Inlightened Partners LLC·Product code ILY·June 4, 2019