20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System
FDA 510(k)
FDA Class 2
·Radiology
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551039020·CRW-ADAPTER GUIDE BUSHING FOR sEEG ANCHOR BOLT ...
Radius Plate PROlock II
FDA UDI
I.T.S. GmbH·09120047296943·Radius Plate PROlock II, 7-Hole, Right
Graseby
FDA UDI
ICU MEDICAL, INC.·00610586100188·
AV 800 VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Support Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·December 27, 2016
L.C. 5000/CE NITROGL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 27, 2009
NITRO I.V. DC INF. SET W/LB TBG
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 16, 2011
L.C. 5000/CE NITROGLYCERIN PUM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 22, 2012
THERMOPHORE HEATING PAD
FDA Adverse Event
BATTLE CREEK EQUIPMENT·Product code IRT·October 21, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013
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 Specialty Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 0 injection sites, PVC Cassette, non-PVC lined tubing, non-PVC drip chamber. Model Number I8C290 (Reorder No. 21-0317-25) for product distributed Internationally. Model Number 8C290 (Reorder No. 21-0304-01) for product distributed within the United States.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004
BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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