17 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ENA EIA KIT
FDA 510(k)
FDA Class 2
·Immunology
TensCare
FDA UDI
TENSCARE LIMITED·05033435135776·The Nouri Digital Electric Breast Pump is a pow...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776363222·Hargis Cheek Retractor
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036006617·
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101070·Distractor, Smooth Paddle, Lordotic, 7mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101070·Distractor, Smooth Paddle, 7mm
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101170·Distractor, Smooth Paddle, Lordotic, 17mm
CTC DVT-1 CALF GARMENT, MODEL DVT-1
FDA 510(k)
FDA Class 2
·Cardiovascular
ENHANCED POLYETHYLENE KNEE PROSTHESES
FDA 510(k)
FDA Class 2
·Orthopedic
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 19, 2013
NONE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·February 11, 2011
PRECISION XTRA/OPTIUM
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·March 10, 2008
DELTAFILL18 10MM X 40CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·September 10, 2020
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024