20 results
·
28ms
·
Sources: EU EUDAMED, US FDA
OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Swish™ Healing Collar
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307116110·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111214974·PEDERSON VAG SPEC MD 7/8X4"
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515229969·Sickle Knife, 7.0mm bld, 6 3/8"
ELTA WOUND CLEANSER
FDA 510(k)
FDA Unclassified
·Unknown
ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ELLIPSE DR, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 30, 2014
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-CLONMEL·Product code MAF·November 20, 2010
UNK
FDA Adverse Event
Injury
·UNK·Product code FTL·December 29, 2012
CORAIL2 NON COL HO SIZE 12
FDA Adverse Event
Injury
·DEPUY FRANCE SAS - 3003895575·Product code KWL·July 14, 2015
TOTAL ASR ACET IMP SIZE 48
FDA Adverse Event
Injury
·DEPUY INTL LTD·Product code KWA·January 31, 2011
TAPER SLEEVE ADAPTER 12/14 +8
FDA Adverse Event
Injury
·DEPUY INTL LTD·Product code KWA·January 31, 2011
DEPUY ASR XL FEM IMP SIZE 43
FDA Adverse Event
Injury
·DEPUY INTL LTD·Product code KWA·January 31, 2011
GMK-REVISION FEMUR REVISION PS SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 18, 2022
CORAIL2 NON COL HO SIZE 10
FDA Adverse Event
Injury
·DEPUY FRANCE SAS - 3003895575·Product code KWY·July 14, 2015
LARGE MOD HEAD ADAPT 12/14 +5
FDA Adverse Event
Malfunction
·DEPUY INTL LTD·Product code KWA·January 31, 2011
DEPUY ASR XL FEM IMP SIZE 43
FDA Adverse Event
Malfunction
·DEPUY INTL LTD·Product code KWA·January 31, 2011
TOTAL ASR ACET IMP SIZE 48
FDA Adverse Event
Malfunction
·DEPUY INTL LTD·Product code KWA·January 31, 2011
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024