23 results
·
20ms
·
Sources: EU EUDAMED, US FDA
EXSALT WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
LANDANGER
FDA UDI
LANDANGER·03661219339281·
MOLAR EXTRACTING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896081574·MOLAR EXTRACTING FORCEPS UPPER TUNGSTEN CARBIDE...
BREG
FDA UDI
BREG, INC.·00672736134023·1 Ice Water Container, 1 12 VDC output and 240 ...
MIKULICZ CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896011540·MIKULICZ CLAMP SHORT JAW
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450238158·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450481912·
HS Stand. Burr, Ø4.0x95, 80k
FDA UDI
Bien-Air Surgery SA·17630055507218·
Tibial Trial UC Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215043001·
ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15
FDA 510(k)
FDA Class 2
·Dental
PALOMAR SLP 1000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 28, 2025
RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code LXH·May 1, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·September 19, 2014
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 13, 2011
5.0CM SHORT ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·September 24, 2015
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
All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: Model 100540 Fleximount SGL Ceiling, Serial No.''s less than SC995486 Model 100740 SGL Ceiling CS II, Serial No''s less than SCCS990745 Model 100580 SGL Trolley, Serial No.''s less than TRS962633 Model 100780 SGL Trolley OP II, Serial No.''s less than STOP97417 Model 102540 SGL Ceiling OP II, Serial No.''s less than SCOP003354.
FDA Recall
Terminated
·Burton Medical Products Corp·Product code KZF·February 19, 2004
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