23 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OSTEO-CABLE SLEEVE
FDA 510(k)
FDA Class 1
·Orthopedic
n/a
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50240221·Rotary instrument für surgical application
Woven Phillips Follower Urethral Bougie
FDA UDI
C. R. Bard, Inc.·00801741073342·Woven Phillips Follower Urethral Bougie
AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 22mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665008722·
WELLS JOHNSON CO.
FDA registration
WELLS JOHNSON CO.·6 products·🇺🇸 United States
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710310240220·Talar Osteotmy Guide, 24mm x 22mm
EndoVive
FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00813939020298·
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710430240220·Medial Malleolar Osteotomy Guide, 24mm x 22mm
M3 (MIRCO-MULTILEAF COLLIMATOR
FDA 510(k)
FDA Class 2
·Radiology
MRI LINE MARKER
FDA 510(k)
FDA Class 2
·Radiology
WELLS JOHNSON INFUSION SYSTEM (WIS)
FDA Adverse Event
Malfunction
·WELLS JOHNSON CO.·Product code FRN·August 12, 2024
CAVITRON SELECT SPS G124 GENERATOR(DNA)
FDA Adverse Event
Malfunction
·DENTSPLY LLC·Product code ELC·June 28, 2024
ENDOVIVE STANDARD BALLOON BALLOON REPLACEMENT KIT, STRAIGHT BOLSTER
FDA Adverse Event
Malfunction
·XERIDIEM MEDICAL DEVICES·Product code KNT·September 2, 2016
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 27, 2013
ACUITY CENTRAL MONITORING
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code DSI·February 15, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 5, 2008
13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.
FDA Enforcement
Class II
·Terminated·Cairn Diagnostics·February 24, 2021
MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code KOD·November 14, 2024
MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code KOD·November 15, 2024
MAGIC3¿ COUDE INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code KOD·November 19, 2024