20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Smart Kit Basic, Smart Kit Pro
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113448·SUPER SHARPS 15 DEG 3MM (BX/5)
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113455·SUPER SHARPS 15 DEG 5MM (BX/5)
SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295083092·SIGMA HP PARTIAL KNEE AP TIBIAL KEEL TRIAL SZ 5-6
SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295083085·SIGMA HP PARTIAL KNEE AP TIBIAL KEEL TRIAL SZ 3-4
SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295083061·SIGMA HP PARTIAL KNEE LAMINA SPREADER
SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295083078·SIGMA HP PARTIAL KNEE AP TIBIAL KEEL TRIAL SZ 1-2
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·August 28, 2020
SPERMASSIST
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COLLAGEN WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·October 14, 2024
UNKNOWN STRYKER RIGHT CONSTRAINED HIP
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·August 5, 2011
SPRINTER RX BALLOON DILATION CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code LOX·October 8, 2008
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 2, 2013
SPYSCOPE DS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FBN·April 29, 2026
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
POWERSUITE
FDA Adverse Event
Injury
·LUMENIS LTD·Product code GEX·April 29, 2026
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
UNK_HARMONIC FCS+
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 30, 2025
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