36 results
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20ms
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Sources: EU EUDAMED, US FDA
ELECSYS TROPONIN I CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EXTRACTING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896048324·EXTRACTING FORCEPS TUNGSTEN CARBIDE DUST TIP #62
House Brand Dentistry
FDA UDI
Frontier Dental Supply Inc·00810132809514·HSB - 3.50" x 9" - Paper/Blue Film Self-Sealing...
Nitanium® Super Elastic Archwires
FDA UDI
Ortho Organizers, Inc.·00190707088125·.018x.025 Upper Nitanium® Dimple Reverse Curve ...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450504765·
HS Dia.Bur,x-crse,Ø4.7x125,80k
FDA UDI
Bien-Air Surgery SA·17630055507355·
N/A
FDA UDI
Doppkon GmbH & Co. KG·04262494461620·BLAKESLEY Biopsy Forceps
D 3.5mm, WL 200mm
DJ ORTHOPEDICS POST SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE
FDA 510(k)
FDA Class 2
·Dental
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 17, 2014
ACCURUS 400VS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 13, 2011
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·January 11, 2018
BD Q-SYTE¿ EXTENSION SET
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·March 23, 2018
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
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 Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FET·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 Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023