20 results
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18ms
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Sources: EU EUDAMED, US FDA
TURBO-RAST SPECIFIC IGE ASSAY
FDA 510(k)
FDA Class 2
·Immunology
Y-PIECE 15M, 15M, 22M/15F + 7.6MM PORTS, PAEDIATRIC
FDA UDI
Intersurgical Incorporated·05030267056132·Y-PIECE 15M, 15M, 22M/15F + 7.6MM PORTS, PAEDI...
30MM UNIFLOW COAXIAL BREATHING SYSTEM 2.4M
FDA UDI
Intersurgical Incorporated·05030267065547·30MM UNIFLOW COAXIAL BREATHING SYSTEM 2.4M
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746111259·DB BKT MINI MS 6.5MM LANG UR CUSP 018 T-3 A+10 R=0
REGATTA LATERAL INSERTER
FDA Adverse Event
Malfunction
·SEASPINE, INC·Product code MAX·May 21, 2024
LINER: MPACT FLAT PE HC LINER Ø36/F
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·January 7, 2020
LINER: MPACT FLAT PE HC LINER 36/F
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 7, 2020
Hydrate
FDA UDI
BRIVANT LIMITED·00816349011504·
Smart Correction
FDA UDI
Wishbone Medical, Inc.·B5621070219030000·Dual Joint Express Strut, Long, Non-Sterile
EMS PIEZON MASTER 700
FDA 510(k)
FDA Class 2
·Dental
GRAMS NYLON NONABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Zimmer® Foot and Ankle System
FDA UDI
Zimmer, Inc.·00889024076570·
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 29, 2024
WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0
FDA Enforcement
Class II
·Ongoing·Wishbone Medical, Inc.·February 15, 2023
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 30, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 12, 2010
EON MINI
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 26, 2012
WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0
FDA Recall
Open, Classified
·Wishbone Medical, Inc.·Product code KTT·January 4, 2023
SINGLE SHOT EPIDURAL ANESTHESIA KIT/Product SKU's (Codes) AK-03000, AM-03000, BH-03000, DH-03000, KC-03000, SA-03001 and SH-03001. Epidural Anesthesia Kit
FDA Recall
Terminated
·Arrow International Inc·Product code CAZ·October 29, 2010
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