24 results
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19ms
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Sources: EU EUDAMED, US FDA
NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS
FDA 510(k)
FDA Class 2
·Orthopedic
PULSE
FDA UDI
Nuvasive, Inc.·00887517973160·PULSE Patient Reference Array Kit
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481110597·LOCATOR R-Tx Abutment for Regular Platform (RP)...
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481114779·LOCATOR F-Tx Abutment for Regular Platform (RP)...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481128769·LOCATOR R-Tx Abutment, Regular Platform (RP) Tr...
IDI Dental Implant
FDA UDI
AIDI BIOMEDICAL LLC·D747IDI10501051·IDI Implant Fixture 5.0mm x 10.5mm
(Implant Pack)
Arthrex®
FDA UDI
ARTHREX, INC.·00888867317093·LOW PROFILE CORTICAL SCW, TI, 5.0x105MM
IDI Dental Implant
FDA UDI
AIDI BIOMEDICAL LLC·D747IDI1050105A1·IDI Implant Fixture 5.0mm x 10.5mm
(Practice Bu...
IDI Dental Implant
FDA UDI
AIDI BIOMEDICAL LLC·D747IDI105010501·IDI Implant Fixture 5.0mm x 10.5mm
(Implant Only)
MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),
FDA 510(k)
FDA Class 2
·Neurology
ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 16, 2026
CONTAK RENEWAL
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 10, 2013
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 1, 2011
MENTOR
FDA Adverse Event
Injury
·Product code FWM·May 21, 2008
EXPEDIUM SINGLE-INNER SETSCREW
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·December 2, 2013
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=112mm, C=82mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-82.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·December 20, 2004
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code OEQ·August 19, 2024
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·October 23, 2024
Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-02130, K05-02595, K09-12599A, K10-05487P, K12-00264, MAP111/F, MAP112/B, MAP112/F, K08-YP085A, K08-YS017B, K08-YS055A, K09-YS029A, K09-YS040F, K12-YP002A, K12-YP030A, K12-YP060A, K12-YP061A, K12-YP063C, K12-YP072, K12-YS018A, K12-YS019A, K12-YS026A, K05-01140D, K05-01706C***, K05-02595, MAP112, K05-00564L, K12-YP002A,
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code DTL·March 1, 2022