7 results
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13ms
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Sources: EU EUDAMED, US FDA
Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.
FDA Enforcement
Class I
·Terminated·Combat Medical Systems, LLC·February 24, 2021
MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·December 23, 2015
Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number
FDA Enforcement
Class II
·Terminated·Trans American Medical, Inc.·January 15, 2014
Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
FDA Enforcement
Class II
·Terminated·Hologic, Inc·September 30, 2020
- Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347 - Fast Cutting Drill Bit 2.0mm Ref. FDB 2.0 Lot 122289, 122322 - Midas Rex Metal Cutting Drill Bit 3.0mm x 18.3mm Ref. MC30 Lot 122347 Orthopedic manual surgical instrument
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH AZARD 30" X 37" (2) MAYO STAND COYER REINFORCED UF (20) GAUZE SPONGE 4" X 4" 1 6PLY XRD UF ( I ) CAUTERY POLISHER TIP LIF ( I ) BLADE SU RGICAL# II CARBON STEEL (I) TRAY MAYO LARGE (8) TOWELS CLOTH I-l UCK (BLUE) (2) WASH BASIN ROUND 6QT ( I ) NEEDLE HYPODERMIC 1 8G X I \12 ST. (2) UTI LITY BOWL QUART 32oz. (2) BULB SYRINGE 60cc LIF (2) NEEDLE & BLADE COUNTER, IOC M/CLEAR LIF (2) PVP SCRUB 8'' STICK SPONGE ST. (I)SKIN STAPLE 35 WIDE ST. LIF (2) SYRINGE 60ML W/0 NEEDLE LILOCK LIF (2) LITE GLOVE (I) TABLE COYER BTC 79" X 110" HD FULL COVERAGE LIF (2) TUBE SUCTION CONNECT. W' X 1 2' LIF (4) DRAPE UTILI TY WIT APE LIF (5) LAP SPONGE PREWASH 1 8" X 1 8" XRD LIF (I) CAUTERY PENCIL ROCKER SWITCH UF (2) BLADE SURG I CA L # I O CARBON STEEL (I) BLADE SURG I CAL#1 5 CARBON STEEL (I) SKIN MARKER INK W/8 LABEL (3) UTI LITY BOWL 1 6oz. L/F (2) PVP PAINT 8" STICK SPONGE ST. (7) DRAPE :V. ECONOMY 53" X 77" LIF (I)S UTURE BAG FLORAL (I) SY RINGE I Occ SLI P TI P ST. LIF (I) NEEDLE HYPODERM IC 22G X I \12 ST. (I) SOLUTION SURG I CAL DURAPREP 26M L LIF (I) GOWN SURG. REINFORCED LGE TOWEL/ WRAP (2) GOWN FAB REINFORCED X-LARGE SONTARA (I) DRAPE TLAPAROT. 1 02" X 78" X 1 21 " STD SMS Product Usage: 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
OPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED L/F (3) TOWEL ABSORBENT 15" X 20" LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SPLIT SHEET BILATERAL 84" X 80" (12) % SHEET 60" X 77" DRAPE REINFORCED LIF (1) MAYO TRAY LARGE (1) CV DRAPE SPLIT CARDIO WITH CLEAR ANEST. SC STD SMS (15) TOWELS CLOTH HUCK BLUE (4) TOWELS CLOTH HUCK WHITE (2) STOCKINETTE IMPERVIOUS 14" X 48" LIF (30) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) WRAPPER 54" X 54" (3) LITES GLOVE LIF OPEN HEART TRAY HOSPITAL HERMANOS MELENDEZ PACKB CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (2) CATHETER THORACIC 32FR. STRAIGH (2) PENCIL CAUTERY ROCKER SWITCH LIF (3) TUBE SUCTION CONNECT W X 12' LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) LABEL SET, HEPARINE SALINE (2) CAUTERY TIP POLISHER LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) BANDAGE ELASTIC 6" X 5yds LIF (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 25G X 5/8 ST. (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) NEEDLE HYPODERMIC 27G X %" ST. (1) NEEDLE & BLADE COUNTER 60C MAG/MAG (2) BOWL UTILITY 16oz. (4) FEEDING TUBE 8FR, 15" LONG (2) BULB SYRINGE 60cc (1) TRAY PLATFORM LARGE (1) SKIN MARKER WITH RULER (1) CATHETER 18FR SUCTION W/STRA LIF (1) WRAPPER 54" X 54" UF (1) BLADE SURGICAL #10 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (2) BLADE SURGICAL #11 CARBON STEEL (1) BLADE SURGICAL #20 CARBON STEEL OPEN HEART TRAY HOSPITAL HERMANOS MELENDEZ PACKC CONTENTS: (9) TOWELS ABSORBENT 15" X 20" UF (6) GOWN FAB REINFORCED SONTARA X-LARGE (1) GOWN IMPERVIOUS XTRA REINFORCED X-LARGE TOWEL & WRAP LEVEL Ill (1) TABLE COVER REINFORCED 44" X 78" UF Product Usage: 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