22 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL
FDA 510(k)
FDA Class 2
·Dental
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950024100·NEEDLEHOLDER BARRAQUER WITH CATCH CVD DEL .5MM ...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481118173·LOCATOR R-Tx Abutment For 3.3mm Premium, Sweden...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694040334·PrimaLIF Implant Tamp
Biliary Drainage Tube
FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170046759·
N/A
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024367401·Folding Bed Cradle
ARTEFILL
FDA Adverse Event
Injury
·SUNEVA·Product code LMH·November 13, 2011
SAFESTING AND SAFESTING HUB
FDA 510(k)
FDA Class 2
·General Hospital
RAPIDVIT BLAST, RAPIDWARM BLAST
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Widex
FDA UDI
Widex A/S·05706069627459·COMPASS GPS V2.1 package (French)
PRISM 6 CHANNEL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code MZA·November 1, 2017
PRISM 6 CHANNEL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code MZA·February 7, 2017
PERCUNAV MP008R-B BUTTON PROBE
FDA Adverse Event
Other
·PHILIPS HEALTHCARE·Product code JAK·October 13, 2010
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code FTL·May 8, 2013
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·April 29, 2011
ASCENSIA BREEZE2
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC·Product code NBW·August 8, 2008
PATIENT WARMING SYSTEM M1000 CONTROL UNIT
FDA Adverse Event
Injury
·O&M HALYARD. INC.·Product code DWJ·August 31, 2022
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 24, 2021
Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-6015
FDA Recall
Terminated
·Product code GBR·July 1, 2003
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017