1,068 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
FDA Recall
Terminated
·Bayer Medical Care, Inc.·Product code JAK·June 28, 2018
Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
FDA Recall
Terminated
·Bayer Medical Care, Inc.·Product code JAK·June 28, 2018
MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL (58-S, 58-P, 85-S, 85-P, 100-S, 100-P, 70Si, 97Si), OCS TRACK (58-S, 58-P, 80-S, 80-P), OCS WALL (S, P), OCS (115A, 115CT, 125CT, 125A, 135A, 135CT, 145, 155A, 165A, 115AS, 115CTS), EOC (700, 700S), EOW 700, EOA 700
FDA Recall
Terminated
·Bayer Medical Care, Inc.·Product code DXT·December 14, 2018
Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material Number 59880288
FDA Recall
Terminated
·Bayer Medical Care, Inc.·Product code JAK·June 28, 2018
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
FDA Recall
Terminated
·Polymedco, Inc·Product code KHE·February 12, 2013
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.
FDA Recall
Terminated
·Polymedco, Inc·Product code KHE·February 12, 2013
Depuy Mitek- Lupine Loop O-C violet Catalog Number: 222980 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·January 27, 2012
Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code OCS·January 17, 2018
ARTISTE and ONCOR Digital Linear Accelerators configured with the 160 leaf Multi-Leaf Collimator (MLC) and MEVATRON and PRIMUS Digital Linear Accelerators configured with the High Performance Defining Collimator (HPD); Product is manufactured by Kemnath, Germany-Siemens AG OCS and Siemens AG, Erlangen, Germany-Siemens AG OCS and distributed by Siemens Medical Solutions, Oncology Care Systems, Concord, CA; Intended to deliver x-ray radiation for therapeutic treatment of cancer. ARTISTE with 160 MLC, Part No.8139789, ONCOR AG with 160 MLC, Part No.5863472 ONCOR Impression Plus with 160 MLC, Part No.5857912, ONCOR Expression with 160 MLC, Part No.7360204, ONCOR Expression with 160 MLC, Part No.7360717, PRIMUS HI with HPD, Part No. 4504200, MEVATRON M2 / PRIMUS Mid-Energy / HPD, Part No.1940035, MEVATRON 6323-2 / HPD, Part No.19244500, MEVATRON K2 / HPD, Part No.1940753, MEVATRON PRIMART / HPD, Part No.5500371, MEVATRON 77 / HPD, Part No.5659503, MEVATRON M 7400 / 7440 (MEX) / HPD, Part No.5672977, MEVATRON M 6700 (MX) / HPD, Part No.5693908, MEVATRON M 6730 / HPD, Part No.5694005, MEVATRON M 7140 / HPD, Part No.5694104, MEVATRON M 7400 / HPD, Part No.5694153, MEVATRON M 7445 / HPD (MEX), Part No.5694203, MEVATRON K 7467 / HPD, Part No.5694252, MEVATRON K 7767 / HPD, Part No.5694302, MEVATRON K 8067 / HPD, Part No.5694401, MEVATRON M 6300 (MX) / HPD, Part No.8317000, MEVATRON M 6730/6740 (MEX) / HPD, Part No.8319758, MEVATRON MD (MD, MDX) / HPD, Part No.8319808, MEVATRON KD / HPD, Part No.8319857, MEVATRON MDX / HPD, Part No.8496200, MEVATRON KD-2 / HPD, Part No.8515520, MEVATRON M3 6300 / HPD, Part No.9401316, MEVATRON M2 6700 / HPD, Part No.9401407, MEVATRON M2 6740 / HPD, Part No.9401506, MEVATRON KDS / HPD, Part No.941522, MEVATRON MD-2 / HPD, Part No.9401654, MEVATRON MDX 2 / HPD, Part No.9401746, MEVATRON KDS-2 / HPD, Part No.9411588, MEVATRON KD-2 / HPD, Part No.9822685, MEVATRON KDS-2 / HPD, Part No.9822693
FDA Recall
Terminated
·Siemens Medical Solutions, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510
4040 Nelson Ave
Concord CA 94520-1200·Product code IYE·August 13, 2010
VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or heparin).
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code LTK·October 9, 2013
MINOR LAPAROTOMY PACK - (1) DRAPE T LAPAROTOMY (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (4) TOWELS ABSORBENT 15" X 20" LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE (1) DRAPE% ECONOMY 53" X 77" LIF (1) CAUTERY PENCIL ROCKER SWITCH (1) UTILITY BOWL 16oz (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR 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 FHI·May 20, 2014
LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD (I) UTILITY BOWL 32oz ( I) GOWN IMP. REINFORCED XL SMS AAMI Ill (2) NEEDLE & BLADE COUNTER I OC MAG/CLEAR ( I) DRAPE LAPAROT ABDOM WITH POUCH (2) TOWELS ABSORBENT 15" x 20" ( I) TIME OUT BEACON NON WOVEN (4) DRAPE UTILITY (I) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (I) MAYO STAND COVER REINFORCED ( I) SUTURE BAG FLORAL (I) TABLE COVER REINFORCED 50" X 90" ( I) GOWN IMP EXTRA REINF LGE TOWEUWRAP (2) DRAPE SHEET 42" X 55" SMS (I) CAUTERY TIP POLISHER (I) CAUTERY PENCIL ROCKER SWITCH ( I) BAG GLASSINE (I) SURGICAL BLADE# 10 STAINLESS STEEL 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 FHI·May 20, 2014
MAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY XRD (1) DRAPE T LAPAROT 102" X 78" X 121" SMS (1) UTILITY BOWL 32oz (1) TUBE CONNECT. SUCTION W X 12' (1) CAUTERY TIP POLISHER (1) YANKAUER SUCTION TUBE W/0 VENT (4) DRAPE UTILITY WITH TAPE (2) LIGHT SHIELD (1) MAYO STAND COVER REINFORCED (4) ABSORBENT TOWELS 15" X 20" (2) DRAPE SHEET 41" X 58" SMS (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR (2) GOWN XL SMS IMPERV. REINFORCED (1) SUTURE BAG FLORAL (1) TIME OUT BEACON NON WOVEN (5) LAP SPONGE PREWASH 18" X 18" XRD (1) SKIN MARKER W/8/LABEL/TIME OUT/RULER 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 PHI·May 20, 2014
LAP AROSCOPY PACK - (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) MAYO STAND COVER REINFORCED L/F (4) ADHESIVE BANDAGE%" X 3" ST. LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (2) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE LASER CAMERA W/EL 6" X 96" LIF (2) LITE GLOVE LIF (1) TUBE SUCTION CONNECTING W X 12' LIF (1) DRAPE LAP WITH POUCH 102" X 121 " X 78" STD SMS (1) BLADE SURGICAL #11 STAINLESS STEEL (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE L/F (1) BAG SUTURE FLORAL (1) TUR Y SET, 2 LEAD L/F (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR LIF (1) GOWN STANDARD LARGE SMS VELCRO NECK (1) TUBE SUCTION CONNECT 3/16" X 12' LIF (1) Pk. STERI STRIP LAP. LATEX (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CAUTERY PENCIL ROCKER SWITCH LIF 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
C-SECTION SURGICAL PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BABY BLANKET PRINTED (1 0) LAP SPONGES PREWASH 18" X 18" XRD (1) BOWL PLASTIC WITH LID 80oz. (1) BAG GLASSINE (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR (1) CORD UMBILICAL CLAMP (2) LIGHT GLOVE (1) BOWL UTILITY 32oz (1) BOWL UTILITY 16oz (4) DRAPE UTILITY (1) TUBE SUCTION CONNECT. 1!4" X 12' (1) TIP CAUTERY POLISHER (1) MUCUSTRAP 20cc, 10FR. (2) DRAPE SHEET 41" X 58" SMS (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE (1) PENCIL CAUTERY ROCKER SWITCH (1) ELECTRODE DUAL DEPRES./GROUNDPAD (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) EAR ULCER SYRINGE 2oz (1) BABY BEANNIES (1) RECEIVING BLANKET 100% COTTON (2) SURGICAL BLADE #10 STAINLESS STEEL 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 OHM·May 20, 2014
LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" LIF (5) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50" X 90" (4) DRAPE UTILITY WITH TAPE (3) DRAPE SHEET 41" X 58" SMS (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR (5) LAP SPONGE PREWASH 18" X 18" XRD (1) GOWN LGE SMS IMPERVIOUS REINFORCED (2) GOWN X-LARGE SMS IMPERV. REINFORCED (2) MEDICINE CUP 2oz. (1) NEEDLE HYPODERMIC 18G X 1% ST. ( 1) BLADE SURG. # 15 CARBON STEEL (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR (1) DRESSING TEGADERM 4" X 4%" (1) SOLUTION SURGICAL DURAPREP 6mL (1) TRAY MAYO SMALL (1) TUBE SUCTION CONNECT. %"X 12' (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) NEEDLE ECLIPSE 22 X 1% (1) TIME OUT BEACON NON WOVEN ST 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
PLASTIC SURGERY PACK- (1) MAYO STAND COVER REINFORCED LIF (1) CAUTERY TIP POLISHER LIF (1) BAG SUTURE FLORAL L/F (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (20) GAUZE SPONGES 4" X 4" 4PL Y (1) COVER TABLE REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) PENCIL CAUTERY HANDSWITCHING L/F (1) TUBE SUCTION CONNECT. ~, X 12' LIF (1 0) LAP SPONGE PRE-WASH XRD LIF (2) LITE GLOVE LIF (4) HUCK CLOTH TOWEL BLUE (2) DRAPE SHEET MEDIUM 41" X 69" LIF (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR LIF (1) DRAPE LAP ABDOMINAL WITH POUCH STD SMS (5) Pk. STERI STRIP CLOSURE %"X 4" L/F (1) MAGNETIC INST. DRAPE (3) SKIN MARKER WITH RULER LIF (1) EXTENDED ELECTRODE BLADE (2) ABSORBENT TOWEL 15" X 20" LIF (4) UTILITY BOWL 32 oz (2) SURGEON GLOVES #8 BIOGEL 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 LRO·May 20, 2014
Universal Pack- - (1) TABLE COVER REINFORCED 50" X 90" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT. X" X 12' LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) BAG SUTURE FLORAL (1) DRAPE TOP WITH ADHESIVE 100" X 53" LIF (1) DRAPE BOTTOM ASS REINFORCED 71" X 71" WITH TAPE LIF (1) CAUTERY TIP POLISHER LIF (3) SURGICAL BLADE #1 0 CARBON STEEL (15) LAP SPONGE PREWASH XRD LIF (1) BAG GLASSINE (2) DRAPE SIDE WITH ADHESIVE 36" X 77" (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F (1) LITES GLOVE LIF (3) SURGICAL BLADE #15 CARBON STEEL (1) SPECIMEN CONTAINER 4oz WITH LID & LABEL (1) WRAPPER 24" X 24" (3) GOWN SURG SMS POLY-REINF. BREATHABLE IMP XLGE AAMI IV 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 OKV·May 20, 2014
CESAREAN PACK - - (1) MAYO STAND COVER REINFORCED LIF (20) LAP SPONGES PRE-WASH XRD LIF (1) UMBILICAL CORD CLAMP LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) BEANNIES BABY (1) POLISHER TIP CAUTERY LIF (1) LITE GLOVE L/F (1) CAUTERY PENCIL ROCKER SWITCH L/F (1) C-SECTION DRAPE WITH POUCH LIF (1) MAYO TRAY SMALL (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) BLADE SURGICAL #10 CARBON STEEL (2) BOWL UTILITY 32oz. LIF (2) PAD OBSTETRICAL X- LARGE LIF (5) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE SHEET 41" X 58" SMS LIF (1) TUBE SUCTION CONNECT. Y.." X 12' LIF (1) EAR ULCER SYRINGE 2oz. LIF (2) GOWM IMPERVIOUS EXTRA REINFORCED X-LARGE (1) RECEIVING BLANKET 100% COTTON (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR LIF 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 OHM·May 20, 2014
C-SECTION PACK - (1) TABLE COVER REINFORCED 50" X 90" L/F (3) TOWELS ABSORBENT 15" X 20" L/F (1) BABY BLANKET (1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERV XL T/ WRAP LEVEL IV (2) PAD OBSTETRICAL XL LIF (1) LITE GLOVE LIF (1) DRAPE SHEET 41" X 69" MEDIUM LIF (2) SURGICAL BLADE #10 CARBON STEEL (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) BAG GLASSINE (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR (1) CONTAINER 64oz WITH LID (1) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF (1) MAYO STAND COVER REINFORCED UF (1) BAG SUTURE FLORAL (15) LAP SPONGES PRE-WASH XRD LIF (1) EAR ULCER SYRINGE 2oz UF (1) CORD UMBILICAL CLAMP L/F (1) WASH BASIN ?QT. (1) CAUTERY TIP POLISHER LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) FEEDING TUBE 8FR. 15" LONG (4) DRAPE UTILITY WITH TAPE UF (1) TUBE SUCTION CONNECT. Y." X 12' UF (2) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERVIOUS XL LEVEL IV 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 OHM·May 20, 2014