3,804 results · 26ms · Sources: EU EUDAMED, US FDA

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EP Catheter Model #'s: BIOD6-DR-005-RT BIOD6-DR-010-RT DAI401381 DAI401449 DAI401904 DAI401915 and EPT7003D Intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and stimulation.

FDA Recall
Terminated ·Sterilmed Inc·Product code NLH·August 8, 2008

Colorado Electrodes Model #'s: COLN104A COLN112A and STRN103A Intended for precision cutting or dissecting and cauterizing soft tissue.

FDA Recall
Terminated ·Sterilmed Inc·Product code JOS·August 8, 2008

Phaco Tips Model #'s: ALC30RTS ALC8065740806 ALC8065740809 ALC8065740837 ALC8065740839 ALC8065750852 ALC8065790020 ALC8065790022 and ALLOPOR3020L Intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.

FDA Recall
Terminated ·Sterilmed Inc·Product code NKX·August 8, 2008

Femoral Compression Device Model #'s: RAD11163 Intended for use in the compression of the femoral artery or vein after cauterization.

FDA Recall
Terminated ·Sterilmed Inc·Product code NMF·August 8, 2008

Laser Probe Model #': SYN55.26.25 Reprocessed laser probes are part of a laser delivery system and are used in opthalmic procedures where laser energy is the mode of treatment.

FDA Recall
Terminated ·Sterilmed Inc·Product code GEX·August 8, 2008

Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05 ETHLCS-C5 and ETHLCSC5HA Intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired.

FDA Recall
Terminated ·Sterilmed Inc·Product code NLQ·August 8, 2008

Stone Retrieval Basket Model #': BOS390-105 Used to entrap and remove renal stones and calculi via a rig id or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures.

FDA Recall
Terminated ·Sterilmed Inc·Product code FFL·August 8, 2008

External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84 SYN394.85 and SYN394.86 Intended for use in the construction of an external fixation frame for treatment of a various fracture types that require external fixation.

FDA Recall
Terminated ·Sterilmed Inc·Product code KTT·August 8, 2008

Masks - Laryngeal Model #'s: AMB321-300-000 AMB321-400-000 AMB321-500-000 LMA12015 LMA12020 LMA12030 LMA12040 LMA12050 LMA12120 LMA12125 LMA12130 LMA12140 and LMA21140 An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.

FDA Recall
Terminated ·Sterilmed Inc·Product code CAE·August 8, 2008

Biopsy Forceps, Cold Model #'s: BAR000386 BAR000388 MIC1012 MIC1331 MIC1333 MIC1337 MIC1536 MIC1589 MIC1597 MIC1598 and MIC1599 The Reprocessed Cold Biopsy Forceps are intended to be used during endoscopic procedures of the gastrointestinal tract to collect tissue samples for histologic examination.

FDA Recall
Terminated ·Sterilmed Inc·Product code NON·August 8, 2008

Biopsy Forceps, Hot Model #'s: BAL60110 BAR000852 BAR000854 and MIC1550 Laparoscopic electric instruments are designed for use in minimally invasive procedures and open surgical procedures to facilitate coagulation, transection, resection, mobilization, and dissection of tissue.

FDA Recall
Terminated ·Sterilmed Inc·Product code NLU·August 8, 2008

Scissor Tips Model #'s: AESPO888 AESPO889 ENCES0102 MIC3112 MIC3122 MIC3142 MIC3152 SNO89-5100 and SNO89-5300 Intended to be used with a resusable hand piece and are designed to use in minimally invasive and open surgical procedures to facilitate coagulation, preparation, mobilization, and cutting tissue.

FDA Recall
Terminated ·Sterilmed Inc·Product code NUJ·August 8, 2008

Reamers Model #'s: HAL5091-144 and ZIMS5979-95-41 An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.

FDA Recall
Terminated ·Sterilmed Inc·Product code HTO·August 8, 2008

Retractors Model #'s: ADE3204 BOS820-175 LON3304 and LON3334-4G A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either resusable or disposable, intended to be used in various general surgical procedures.

FDA Recall
Terminated ·Sterilmed Inc·Product code GAD·August 8, 2008

Lap Instruments/Graspers/Forceps - HOT Model #'s: AUT173016 AUT174301 AUT176643 AUT176643 ETH5DCD ETH5DCS ETHEBF01 ETHPOUCH GYR3000PK GYR3005PK GYR3640 and GYR920005PK Laparoscopic electric instruments are designed for use in minimally invasive procedures and/or open surgical procedures to facilitate coagulation, transaction, resection, mobilization and dissection of tissue.

FDA Recall
Terminated ·Sterilmed Inc·Product code NUJ·August 8, 2008

Rasps Model #'s: KOMKM5100-37-113 KOMKM-82 STR1675-115 STR5100-37-113 and STR5100-37-115 A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either resusable or disposable, intended to be used in various general surgical procedures.

FDA Recall
Terminated ·Sterilmed Inc·Product code HTR·August 8, 2008

Taps Model #'s: SYN311.15 SYN311.190 SYN311.39 and SYN311.32 An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.

FDA Recall
Terminated ·Sterilmed Inc·Product code HWX·August 8, 2008

Lap Instruments/Graspers/Forceps - COLD Model #'s: AUT173030 AUT174233 AUT174317 AUT176613 AUT176647 AUTECATCH10G and ETH5DSG A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either resusable or disposable, intended to be used in various general surgical procedures.

FDA Recall
Terminated ·Sterilmed Inc·Product code GDI·August 8, 2008

Balloon Inflation Device Model #'s: MED15-105 MED15-106 and SCI04527-01 The reprocessed Balloon inflation device is intended for use with balloon dilatation catheters to create and monitor pressure in the ballon and to deflate the ballon.

FDA Recall
Terminated ·Sterilmed Inc·Product code NKU·August 8, 2008

Guidewires - Endoscopic (Jag Wires) Model #'s: MIC5658 and MIC630-100 Intended to be used for selective cannulization of the billary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic billary procedures for catheter introduction and exchanges.

FDA Recall
Terminated ·Sterilmed Inc·Product code NML·August 8, 2008