20 results · 21ms · Sources: EU EUDAMED, 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