1,216 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code MED·August 10, 2015
CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code MED·June 1, 2012
CIDEX OPA Solution, ortho-Phthalaldehyde Solution
FDA Recall
Terminated
·Advanced Sterilization Products·Product code MED·April 12, 2004
Ortho-phthaladehyde Concentration Indicator Browne CIDEX OPA Indicator
FDA Recall
Terminated
·Advanced Sterilization Products·Product code JOJ·September 4, 2003
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code EOQ·April 1, 2022
11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FAJ·April 1, 2022
11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FBO·April 1, 2022
CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FBO·April 1, 2022
11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code EOB·April 1, 2022
11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FBO·April 1, 2022
11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018);
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FGB·April 1, 2022
11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FBO·April 1, 2022
11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FGB·April 1, 2022
11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FBO·April 1, 2022
11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VSUA 11278VSUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSUE 11278VSUEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020)
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FGB·April 1, 2022
11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VSUA 11278VSUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSUE 11278VSUEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020)
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code FGB·April 1, 2022
EvoTech Endoscope Cleaner & Reprocessor, Product Code 50004 Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and high level disinfection of heat sensitive semi-critical endoscopes.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code FEB·February 13, 2008
EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002 Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and high level disinfection of heat sensitive semi-critical endoscopes.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code FEB·February 13, 2008
EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60C} semi-critical endoscopes.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code FEB·September 27, 2016
EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 C) semi-critical endoscopes.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code FEB·May 11, 2015