19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777518·LUMBAMED PLUS FLEX PAD M SILVER IV
CoRoent
FDA UDI
Nuvasive, Inc.·00887517578426·CoRoent Ant TLIF Ti, 11x10x32mm 4°
Kompressor™ Compression Screw System
FDA UDI
Ascension Orthopedics, Inc.·10381780065760·The mini Kompressor Compression Screw is a two-...
FAA Airline - 24 Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588013244·FAA Airline - 24 Poly White
ELMED
FDA UDI
ELMED INCORPORATED·00842180109643·3 MM DIA., 45 CM INSULATED BUTTON ELECTRODE
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551068266·LEKSELL KIT: 2103-39, 2103-26, 2103-58, 2103-59...
NHancer Rx
FDA 510(k)
FDA Class 2
·Cardiovascular
STA-QUALITY HBPM/LMWH KIT
FDA 510(k)
FDA Class 2
·Hematology
IAG BC PRO GLOBAL GRN 18GA X 1.16IN
FDA Adverse Event
Malfunction
·Product code FOZ·June 11, 2021
ANCURE ENDOGRAFT
FDA Adverse Event
Injury
·GUIDANT ENDOVASCULAR SOLUTIONS·Product code MIH·October 21, 2008
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 9, 2011
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
FDA Enforcement
Class II
·Terminated·Reflexion Medical, Inc.·January 19, 2022
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Primary Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 standard injection sites. Model Number I8C230 (Reorder No. (21-0345-25) for product distributed Internationally. Model Number 8C230 (Reorder No. 21-0324-01) for product distributed within the United States.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004
Alinity m System, Part No. 08N53-002
FDA Enforcement
Class II
·Terminated·Abbott Molecular, Inc.·January 12, 2022
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017