18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ProCinch Adjustable Loop Device
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768505·GENUMEDI PSS GREEN VI
AGXO
FDA UDI
Oticon A/S·05707131288592·H110V2, DESIGNRITE 10 WL SIL AGXO
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304239395·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197541800·RZ Tebbet Breast Retractor
150x16...
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962104767·FULL RADIUS BLADE, SMALL JOINT, 2.9MM, S
DORNIER HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·DORNIER MEDTECH AMERICA, INC.·Product code LNK·July 13, 2007
ABL835 FLEX ANALYZER WITH PLEURAL PH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OSSAPLAST ORTHO
FDA 510(k)
FDA Class 2
·Orthopedic
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962102770·DISPOSABLE ARTHROSCOPIC 2.9mm FULL RADIUS SHAVE...
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·March 31, 2016
BALLOON
FDA Adverse Event
BOSTON SCIENTIFIC·Product code KNQ·June 21, 2011
UNKNOWN ZIMMER HIP
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDI·March 19, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 5, 2008
TREVO XP PROVUE 4MM X 30MM
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code NRY·July 24, 2020
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
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
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024