51 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OMNILUX BLUE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pratt Ex large, Light Weight
FDA UDI
MEDGYN PRODUCTS, INC.·M803030883·Pratt Ex large, Light Weight 53-55 Fr (17.6-18....
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0380830·T-Handle, Ratcheting, Quarter Square Collar
GentleLase
FDA UDI
Candela Corporation·00817495022703·Pulsed Laser
MOLINA ORBITAL MALAR DISTRACTOR
FDA 510(k)
FDA Class 2
·Dental
TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE
FDA 510(k)
FDA Class 2
·Radiology
OPTETRAK
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 2, 2022
LOGIC TIBIA PS MOD INSRT SZ 3 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 2, 2022
LOGIC TIBIA PS MOD INSRT SZ 5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 23, 2022
COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAM·April 2, 2013
CONSTELLATION WITH LASER
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 4, 2011
GE OEC 9400
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008
OPTETRAK
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 4, 2022
LOGIC TIBIA PS MOD INSRT SZ 4 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 3, 2024
LOGIC TIBIA PS MOD INSRT SZ 5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 10, 2023
LOGIC TIBIA PS MOD INSRT SZ 5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 10, 2023
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 11, 2024
ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 6, 2025
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 11, 2024