13 results · 21ms · Sources: EU EUDAMED, 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