27 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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OncoMate MSI Dx Analysis System
FDA 510(k)
FDA Class 2
·Immunology
7000 CONNECTORS
FDA UDI
HANS RUDOLPH, INC.·00817136022154·CONN 35IDORG X 25.4IDORG 7000
Cut Guide
FDA UDI
Treace Medical Concepts, Inc.·00810111222051·MTA Stepped Cut Guide
GERALD FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060128·GERALD FORCEPS STRAIGHT TEETH
Initia Total Hip System
FDA UDI
KYOCERA CORPORATION·04547898306280·STD LINER 32-56/58
Initia Total Hip System
FDA UDI
KYOCERA MEDICAL CORPORATION·04580810057983·"STD LINER 32-56/58
Size:32-56/58
Type:Flat
32m...
Ortho Organizers
FDA UDI
Ortho Organizers, Inc.·00190707040802·MOSQUITO FORCEPS- 1/2" FINE TIP
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
FDA 510(k)
FDA Class 2
·Cardiovascular
PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962160275·NANO PLASTIC TRAY, 7"X2"X3 1/2", W/SILICONE MAT
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 29, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 28, 2025
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 10, 2016
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 10, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 15, 2008
FF 360
FDA Adverse Event
Malfunction
·SMITH & NEPHEW MANSFIELD MANUFACTURING SITE·Product code GAT·July 1, 2013
MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·March 8, 2024
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·September 29, 2021
iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.
FDA Enforcement
Class II
·Terminated·Abbott Laboratories, Inc·March 13, 2019