23 results · 27ms · 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.

PREZAPAK L ARTERIAL BLOOD SAMPLING KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Precept

FDA UDI
Nuvasive, Inc.·00887517345363·PRECEPT Screwdriver, Polyaxial

Vista 1.5mm Frazier Style Surgical Aspirator

FDA UDI
Vista Dental·10818207021486·

N/A

FDA UDI
inomed Medizintechnik GmbH·04250307605736·RM dove tail guide, short

N/A

FDA UDI
inomed Medizintechnik GmbH·EINO8010159·RM dove tail guide, short

Perfect Fit

FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377022166·FastTrack Demo Kit, Pediatric, Universal

Perfect Fit

FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377022173·FastTrack Demo Kit, Adult, Universal

INTRA-AORTIC BALLOON CATHETER

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·August 27, 1998

ELECSYS THYROGLOBULIN CALCHECK

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CERALAS D 980NM DIODE LASER, MODELS D15 AND D25

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Fragment Case

FDA UDI
Zimmer, Inc.·00889024068070·

M2A-MAGNUM MOD HD SZ 56MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 8, 2014

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 21, 2007

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Injury ·TANDEM DIABETES CARE INC.·Product code LZG·May 27, 2015

ALL-IN-ONE CCU+LIGHT ROW

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code FCW·July 28, 2020

Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

FDA Enforcement
Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

FDA Enforcement
Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

FDA Enforcement
Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

FDA Enforcement
Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

FDA Enforcement
Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015