3,158 results
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11ms
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Sources: EU EUDAMED, US FDA
Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.
FDA Enforcement
Class II
·Terminated·Argon Medical Devices, Inc·June 14, 2017
BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.
FDA Enforcement
Class II
·Terminated·Baylis Medical Company Inc.·March 6, 2013
First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 7, 2020
Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems, Inc.·November 19, 2014
Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems, Inc.·November 19, 2014
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
ANGIODRAPE PACK - - (1) GUIDEWIRE 0.035" X 150cm (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK UF (2) Pr. SURGICAL GLOVES #8 (2) GOWN STANDARD LARGE SMS VELCRO NECK (2) NEEDLE HYPODERMIC 21G X 1 W' UF (1) TABLE COVER 44" X 90" (3) CLOTH HUCK TOWELS BLUE (2) UTILITY BOWL 16oz L/F (1) SOLUTION SURGICAL DURAPREP 26ML UF (3) DRAPE UTILITY WITH TAPE UF (3) TOWEL CLAMP (2) TOWELS ABSORBENT 15" X 20" UF (1) NEEDLE 18G X 2% AMC/4 (1) FEMORAL ANGlO DRAPE WITH POUCH UF (1) BAND BAG RUBBAND & TAPE UF (1) CUP DENTURE WITH LID (30) GAUZE SPONGE 4" X 4" 12PL Y (2) TIP ASBORBENT APPLICATOR STICK SPONGE (1) SCALPEL WITH HANDLE #11 (1) STOPCOCK 3 WAY (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK 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
ANGIOGRAPHY PACK - ( 1) FEMORAL ANGlO. DRAPE WITH POUCH (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 21G X 1% ( 1) TABLE COVER REINFORCED 44" X 78" LIF (30) GAUZE SPONGES 4" X 4" 12PLY ( 1) GOWN IMPERVIOUS REINFORCED LARGE SMS ( 1) GOWN LARGE NON REINFORCED SMS TOWEL & WRAP ( 1) GUIDEWIRE .035" X 150cm MOVABLE (2) BAND BAG RUBBAND & TAPE L/F (2) DENTURE CUP 8oz. WITH LID ( 1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF ( 1) NEEDLE HYPODERMIC 18G X 1 % ( 1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F (4) DRAPE UTILITY WITH TAPE L/F (2) SOLUTION SURGICAL DURAREP 6ml L/F (2) TOWEL CLAMP (1) NEEDLE 18G X 2% AMC/4 (4) TOWELS CLOTH HUCK BLUE ( 1) UTILITY BOWL 16oz. LIF ( 1) SCALPEL WITH HANDLE # 11 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
ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48" M/F (1) ANG. FEMORAL DRAPE WITH POUCH UF (1) PLATFORM TRAY LARGE (3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) BAG BAND RUBBAN & TAPE UF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (5) ABSORBENT TOWELS 15" X 20" LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL DURAPREP SOLUTION 6ML LIF (1) SAFETY SCALPEL #11 STAINLESS STEEL (2) GOWN STANDARD SMS LARGE VELCRO NECK (1) MANIFOLD WITH CONTROL SYRINGE (1) NEEDLE 18G X 2% AMC/4 (2) UTILITY BOWL 16oz UF (2) CLOTH HUCK TOWEL BLUE (2) NEEDLE HYPODERMIC 21 G X 1 ~ LIF (2) MEDICINE CUP 2oz LIF (30) GAUZE SPONGE 4" X 4" 16PL Y (1) NEEDLE HYPODEMIC 18G X 1 ~ (4) TOWEL CLAMP (2) SYRINGE 3cc WITHOUT NEEEDLE LUER LOCK LIF (1) HALSTED MOSQUITO CVD 5" SERRAT (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (2) NEEDLE HYPODERMIC 22G X 1 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
FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50" X 90" UF (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF (1) TOWEL ABSORBENT 15" X 20" UF (1) DRAPE ANGlO 75" X 145" (4) TOWELS CLOTH HUCK (BLUE) UF (3) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF (1) IV ADM SET 15ML 1 06" LONG LIF (20) GAUZE SPONGE 4" X 4" 12PL Y LIF (1) NEEDLE HYPODERMIC 18G X 1Y:. ST. UF (1) NEEDLE HYPODERMIC 21G X 1Y:. ST. LIF (2) MEDICINE CUP 2oz. CLEAR LIF (1) SCALPEL WEIGHTED SAFETY #11 (2) CHLORASCRUB SWABSTICK 5.1 ML LIF (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP LIF (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL LIF (1) NEEDLE HYPODERMIC 25G X 5/8 ST. LIF (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) FORCEP ADS ON TISS. WITH TIP LIF (1) UTILITY BOWL 32oz LIF (1) UTILITY BOWL 16oz L/F (1) FORCEP KELLY STRAIGHT 5.5" LIF (1) MOSQUITO HALSTED CVD 5" LIF (1) TRAY ORGANIZER FULL DEEP LIF (1) SCISSOR MAYO 6.75 STRAIGHT LIF (1) HOLDER NEEDLE WEBSTER 4.75 LIF (1) GUIDEWIRE .035" X 150cm UF (1) TIME OUT BEACON NON WOVEN ST. UF (1) MAYO TRAY SMALL LIF (2) TOWEL CLAMP UF (2) BAG BAND RUBBAND & TAPE LIF (1) Pr. GLOVE SURG. #7Y:. DERMA PRENE P/F LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF LABEL SAMPLE (1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF (1) NEEDLE 18G X 2 o/.i AMC/4 (1) SKIN MARKER INK WITH/8 LABEL 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
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·October 22, 2014
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
FDA Enforcement
Class II
·Terminated·Covidien Llc·August 18, 2021
First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)
FDA Enforcement
Class II
·Terminated·ASO LLC·May 11, 2022
Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020
Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020
Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020
Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
FDA Enforcement
Class II
·Terminated·Covidien LLC·February 26, 2020
8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
FDA Enforcement
Class II
·Terminated·COVIDIEN LLC·December 26, 2018
Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099
FDA Enforcement
Class II
·Terminated·Covidien LLC·December 21, 2016