15 results · 30ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

HANSON MEDICAL CALF IMPLANT

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Hern Dilator

FDA UDI
MEDGYN PRODUCTS, INC.·M803030808·Hern Dilator 44Fr (14.6 mm)

Vario

FDA UDI
Ropox A/S·05707581000560·

MiroDerm Fenestrated Plus

FDA UDI
REPRISE BIOMEDICAL, INC.·00857072005248·8 x 8 cm Fenestrated Plus Biologic Wound Matrix

TAKE 1

FDA 510(k)
FDA Class 2 ·Dental

RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE

FDA 510(k)
FDA Class 2 ·Physical Medicine

PRISM NUCLEAR GAMMA CAMERA SYSTEM

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.·Product code KPS·March 27, 2013

MICRO INTRODUCER SHEATH SET

FDA Adverse Event
Malfunction ·ARGON MEDICAL DEVICES, INC.·Product code DRE·March 22, 2011

PRO OSTEON 500

FDA Adverse Event
Malfunction ·EBI, L.P.·Product code MBS·April 17, 2008

ALINITY M RESP-4-PLEX AMP KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

ALINITY M RESP-4-PLEX AMP KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

ALINITY M RESP-4-PLEX AMP KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

ALINITY M RESP-4-PLEX AMP KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

ALINITY M RESP-4-PLEX AMP KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 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