13 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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DR GREENBURGS HYBRID VACUUM
FDA 510(k)
FDA Class 2
·Dental
BullDog
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734021347·BullDog Disposable Endoscope Valves Set
BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·December 23, 2021
SAFECT MODEL VER 1.0
FDA 510(k)
FDA Class 2
·Radiology
OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRIME ZOOM STRETCHER,30"LITTER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code INK·May 20, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 10, 2011
ASANTE SNAP INSULIN PUMP SYSTEM
FDA Adverse Event
Injury
·ASANTE SOLUTIONS INC.·Product code LZG·August 11, 2014
Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72
FDA Recall
Terminated
·GA HEALTH COMPANY LIMITED
Unit 18, 21/F
Metropole Square; 2 On Yiu Street ,Shatin, N.T
Shatin N.T. Hong Kong SAR·Product code OCX·November 3, 2020
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015