26 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EVIS EXERAII 180 SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·September 25, 2023
Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FET·September 25, 2023
LANDANGER
FDA UDI
LANDANGER·03661219339328·
SONTEC DENTAL BONE CUTTING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896048171·SONTEC DENTAL BONE CUTTING FORCEPS SMALL SIZE
Nitanium® Super Elastic Archwires
FDA UDI
Ortho Organizers, Inc.·00190707088064·.018 Upper Nitanium® Dimple Reverse Curve of Sp...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450504765·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450483299·
HS Stand. Burr, Ø4.0x125, 80k
FDA UDI
Bien-Air Surgery SA·17630055507256·
Tibial Trial UC Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215043049·
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
MULTI FRAME WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
SMS SOLID STEM LAT SIZE 10
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 22, 2023
XRL MEDIUM CENTR BOD H44-59
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code MQP·July 16, 2013
MBT REVISION CEM TIB TRAY SZ 4
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·May 17, 2011
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 17, 2014
MEDIVATORS AUTOMATED SCOPE REPROCESSOR DSD-201
FDA Adverse Event
Injury
·MINNTECH CORP·Product code FEB·August 5, 2008
20 ML BD LUER-LOK SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·November 27, 2020