BEUDAMED
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    BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc.·April 20, 2016

    Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin is used to guide reamers down the humeral canal during a Uniflex Humeral Nail procedure. A 467255-02 Plain Guide Pin is used to guide a Uniflex Humeral Nail implant into the humeral canal after the fracture has been reduced.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 26, 2016

    Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·April 1, 2020

    Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP000525 5.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB0110 1PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB0112 10 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB0120 1PK PHANTOM FIBER SZ 2 VIOLET SMSB0120N lPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0122 10 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N 10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0130 1PK PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB0132 10 PK PHANTOM FIBER SZ 2 WHITE/VIOLET Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·April 25, 2018

    Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK; 516V2S/ Skull Pin 3in TI Sterl 1PK; 520TS/ Skull Pin 2-1/4in TI Sterl 5PK; 520V2S/ Skull Pin 3in TI Sterl 5 PK

    FDA Enforcement
    Class II ·Terminated·Ossur Americas·March 20, 2019

    Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl 1PK; 516DS/ Skull Pin 3in CT Sterl 1PK; 517CS/ Skull Pin 2-1/4in CT Sterl 4PK; 517DS/ Skull Pin 3in CT Sterl 4 PK; 522CS/ Skull Pin 2-1/4in CT Sterl 6PK; 522C/ SKULL PIN 2-1/4 CT 6 PK

    FDA Enforcement
    Class II ·Terminated·Ossur Americas·March 20, 2019

    NEURO PACK - (1) CAUTERY TIP POLISHER LIF (4) DRAPE UTILITY WITH TAPE LIF (1) INSTRUMENT POUCH (10) LAP SPONGE PRE-WASH XRD (1) Pk. SURGICAL STRIP W' X 6" (2) UTILITY BOWL 32oz (1) MAYO TRAY LARGE (9) SHEET DRAPE 41 " X 69" MEDIUM LIF (1) NEEDLE HYPODERMIC 18G X 1 LIF (3) CONTAINER SPECIMEN 4oz WITH LID & LABEL (2) Pr. SURGICAL GLOVES 7 Y2 (2) Pr. SURGICAL GLOVES 8 (2) EAR ULCER SYRINGE 2oz LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) SHEET MINOR LAP 102" X 121" X 78" (1) SAFETY SCALPEL #10 (2) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF (4) CLOTH HUCK TOWELS BLUE (1) PENCIL CAUTERY ROCKER SWITCH (2) LEGGINS W/7'' CUFF 30" X 42" (1) DRAPE% ECONOMY 53" X 77" LIF (1) Pk. SURGICAL STRIP 'X" X 6" (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F (2) ROUND WASH BASIN 6QT (2) GOWN SURG. REINFORCED TOWEL/WRAP LARGE (2) Pr. SURGICAL GLOVES 7 (1) SKIN MARKER WITH RULER LIF (1) Pk. STERI STRIP CLOSURE %"X 4" LIF (1) TUBE SUCTION CONNECT. 'X" X 12' LIF (1) SAFETY SCALPEL #15 (1) SAFETY SCALPEL #11L/F 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

    TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER REINFORCED LIF ( 1) CAUTERY TIP POLISHER LIF (8) TOWEL CLOTH HUCK (BLUE) ( 1) BULB SYRINGE 60cc LIF ( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE (2) LITE GLOVE ( 1) TUBE SUCTION CONNECT. Y.." X 12' LIF ( 1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF ( 1) DRAPE % ECONOMY 53" X 77" LIF ( 1) SHEET SPLIT W/ADHESIVE 77" x 146" (2) GOWN XL SMS IMPERVIOUS REINFORCED LIF (2) SYRINGE 60ml WITHOUT NEEDLE LUER LOCK LIF ( 1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF ( 1) STAPLE SKIN 35 WIDE LIF ( 1) TRAY MAYO LARGE (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF ( 1) SOLUTION SURGICAL DURAPREP 26ml LIF ( 1) Pk. NEUROPATTIES 0.45MM 10ea/pk ( 1) Pk. NEUROPATTIES 0.35MM 10ea/pk 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

    PATIENT TRACKER 9733534XOM ENT 1PK

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·November 26, 2014

    INSTRUMENT TRACKER 9733533XOM ENT 1PK

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·November 26, 2014

    DISP 9730950 STRL SPHERE, 1 PK INSERT

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·November 26, 2014

    ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·June 12, 2013

    D & C LAPAROSCOPY PACK - (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT (1) MAYO STAND COVER REINFORCED UF (4) DRAPE UTILITY UF (1) TRAY MAYO SMALL LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) SUTURE BAG FLORAL LIF (1) TUBE SUCTION CONNECT X" X 12' LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) LEGGINGS WITH 7" CUFF 30" X 42" LIF (1) UTILITY BOWL 32oz. UF (1) *FOLEY CATHETER 5CC/2 WAY 16FR SILICONE COATED LATEX (2) DRESSING NON ADH TELFA 4 X 3 ST. UF (1) JELLY LUBRICATING FIVE GRAM (1) TABLE COVER REINFORCED 50" X 90" LIF (1) *Pk. STERI STRIP LAP SET LATEX (1) COVER CAMERA W/ELAST UF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED UF (4) TOWELS ABSORBENT 15" X 20" UF (1) DRAPE LAP. PERINEAL WITH POUCH 102" X 97" SOFT SMS UF (2) LIGHT SHIELD (1) DRESSING TEGADERM 4" X 4 %" LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP (1) SCALPEL WEIGHTED SAFETY #11 (1) BAG ZIP LOCK (1) Pk. STRIP STERI CLOSURE W' X 4" LIF (1) TIME OUT BEACON NON WOVEN ST. UF (1) BANDAGE GAUZE STRETCH 4" (1) NEEDLE ULTRA VERES 120MM UF (2) COUNTER NDUBLADE, 10C MAG/CLEAR UF (1) SKIN MARKER INK WITH 8 LABEL !TIME OUT/RULER L/F 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

    GAUZE SPONGES 2"x2" 4 PLY ST 2/PK 1500PK/CS 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

    G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 27, 2018

    G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 27, 2018

    G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 27, 2018

    Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1) SHEET ENT SPLIT 11 0" X 77" SMS (1) COVER TABLE REINFORCED 44" X 78" (20) GAUZE SPONGE 4" X 4" 12PL Y (6) TOWEL CLOTH HUCK BLUE (1) PK. STRIP STERI CLOSURE W X 4" (2) CUP DENTURE 8oz TEAL WITH LID (1) SKIN MARKER WITH RULER (1) RULER (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK (1) SHEET o/. DRAPE 60" X 77" REINFORCED (1) BLADE SURG. #15 CARBON STEEL (1) BLADE SURG. #10 CARBON STEEL (4) DRAPE UTILITY WITH TAPE (1) SYRINGE BULB 60CC (2) Prs. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 6.5 P/F (2) Prs. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7 P/F (1) Pr. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7.5 P/F (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) TUBE SUCTION CONNECT%'' X 12' (1) CAUTERY PENCIL PUSH BOTIOM HOLSTER 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

    General Cosmetic Pack FCSC, Code 900-3113, contains: (1) COVER MAYO STAND REINFORCED LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF (2) GOWN LARGE STANDARD SMS AAMIIII (1) TABLE COVER REINFORCED 50" X 90" LIF (2) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) SYRINGE BULB 60CC LIF (1) BLADE SURGICAL #15 CARBON STEEL (1) NEEDLE HYPODERMIC 18G X 1% LIF (6) TOWEL CLOTH HUCK BLUE LIF (4) DRAPE UTILITY WITH TAPE L/F (1) NEEDLE HYPODERMIC 25 X 1% L/F (1) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10CC WITHOUT NNEDEL LUER LOCK LIF (2) NEEDLE SPINAL ANESHT 20G X 3%" LIF (1) SKIN MARKER WITH RULER LIF (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F (1) LITE GLOVE (1) DRAPE BREAST/CHEST SMS LIF (1) TUBE SUCTION CONNECT%" X 12' LIF (10) GAUZE SPONGE 4" X 4" 16PLY L/F (2) GLOVE MEDIUM FREETOOUCH VYNIL POWDER FREE (1) TRAY 3/COMPARTMENT (1) WRAPPER 24" X 24" L/F (2) PK. SURG. GLOVE# 7% ENCORE POWDER FREE LATEX 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

    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 Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014