40 results
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31ms
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Sources: EU EUDAMED, US FDA
PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE
FDA 510(k)
FDA Class 2
·Ophthalmic
Zimmer
FDA UDI
Preat Corporation·00842092100486·Zimmer® TSV-compatible 3.5/4.5/5.7mm Guide Pin ...
Implant Prosthetics
FDA UDI
Preat Corporation·00842092127353·Zimmer® TSV-compatible 3.5/4.5/5.7mm Guide Pin ...
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037307380·LEFT AIMER PRCT II
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151801·IN-OVATION® C EURO 018 U5-5 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151101·IN-OVATION® C Base Rx 018 UP5-5 CHK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151111·IN-OVATION® C Base Rx 018 U5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151811·IN-OVATION® C EURO 018 U5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151001·IN-OVATION® C Base Rx 018 U5-5
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151611·IN-OVATION® C Roncone 018 U5-5 CS BC HK
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ACTICOAT FOAM DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·January 26, 2025
CRE 18-20MM 8CM F/G
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORK LTD.·Product code KNQ·March 21, 2007
RANGER MONITOR W/SNAPS, LARGE & POWER SUPPLY
FDA Adverse Event
Malfunction
·VERATHON MEDICAL (CANADA) ULC.·Product code CCW·February 14, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·February 24, 2011
RESTORE PRIME
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·February 19, 2008
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
FDA Recall
Completed
·Percussionaire Corporation·Product code CBK·September 14, 2020
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
FDA Enforcement
Class II
·Completed·Percussionaire Corporation·November 15, 2023
LEEP SYSTEM 1000 ESU GEN
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code HGI·September 20, 2021