19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nexxt Matrixx System
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517576378·CoRoent Ant TLIF Ti, 9x11x40mm 8°
Orthos
FDA UDI
ORMCO CORPORATION·00889989030037·ORTHOS CM SST 016 X 022 UPLG PK10
Life Instruments
FDA UDI
Life Instrument Corporation·M930719140830·Custom Teardrop Curette 8mm 50° Lateral Angle
Life Instruments
FDA UDI
Life Instrument Corporation·M930719140810·Custom Teardrop Curette 8mm 20° Fwd Angle
Life Instruments
FDA UDI
Life Instrument Corporation·M9307191408300·Custom 6.5mm Lateral Ang Teardrop Curette w/4.5...
Life Instruments
FDA UDI
Life Instrument Corporation·M9307191408100·Custom 6.5mm Teardrop Curette w/4.5" Handle
MICROGARD II
FDA 510(k)
FDA Class 2
·Anesthesiology
DISPOSABLE PRESSURE TRANSDUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 1, 2015
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
SIMPLEX P-JAPANESE TWIN PACK
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS LIMERICK·Product code LOD·July 28, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 26, 2013
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 26, 2008
UNK HIP FEMORAL STEM SROM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 20, 2022
UNK HIP FEMORAL SLEEVE SROM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 20, 2022
Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016