20 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
FDA 510(k)
FDA Class 2
·Ophthalmic
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950017300·RETRACTOR FARABEUF D/E SET OF 2 6" 15CM
KNOWLES BANDAGE SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896046504·KNOWLES BANDAGE SCISSORS STRAIGHT BLADE
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037313428·LOCK
DURAVENT
FDA UDI
Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948004816·DURAVENT 2 IC, SIZE 7
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTL.·Product code MNI·October 14, 2011
POROCOAT PRODIGY HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
PORTABLE INSTENSIVE CARE UNIT
FDA 510(k)
FDA Class 3
·Cardiovascular
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011
TELIGEN
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LWP·May 8, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·May 16, 2011
NEURAGEN 3MM X 2CM 1 UNIT
FDA Adverse Event
Other
·INTEGRA LIFESCIENCES·Product code JXI·July 31, 2008
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
PRODIGY LG STAT SHT LT 12.0MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 2, 2016
PRODIGY LG STAT LNG LT 13.5MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·June 3, 2018
Alinity m System, Part No. 08N53-002
FDA Enforcement
Class II
·Terminated·Abbott Molecular, Inc.·January 12, 2022
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025