21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STEELEX STERNUM SET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONMED
FDA UDI
Conmed Corporation·10845854009215·GRAFT HARVESTING BLADE 11 X 20 MM
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134110·Trial, TLIF, 27L OB STR 7Deg, 11mm
True Position®
FDA UDI
ATLAS SPINE, INC.·M68112080234110·34mm x 11mm Non-Lordotic Spacer
ELECSYS TESTOSTERONE CALSET II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PULPDENT CAVITY PREPARATION IV
FDA 510(k)
FDA Class 2
·Dental
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021
TSVMWB11
FDA Adverse Event
Malfunction
·ZIMMER DENTAL-2023411·Product code DZE·October 4, 2018
ASPHERE M SPEC 11/13 40 +3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·March 27, 2013
DEPUY ASR XL FEM IMP SIZE 45
FDA Adverse Event
Malfunction
·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 2, 2011
LEEP
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code HGI·April 2, 2008
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 2, 2019
FREEDOM SPINAL CORD STIMULATOR
FDA Adverse Event
Injury
·STIMWAVE TECHNOLOGIES INC.·Product code GZB·May 12, 2020
COMP LK SCR 3.5HEX 4.75X45 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·October 10, 2023
COMP LK SCR 3.5HEX 4.75X40 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·October 10, 2023
COMP LK SCR 3.5HEX 4.75X45 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·October 10, 2023
COMPR VRS GLEN PPS MIN TPR ADR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·October 10, 2023
COMP LK SCR 3.5HEX 4.75X45 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·October 10, 2023
COMP LK SCR 3.5HEX 4.75X45 ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·October 10, 2023
Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Model Number 400, 404, V400, V450; 3. Lap 18X18 XR w/ring (5 each/pack, 40 pack/case) - Model Number 402; 4. Lap 4X18 XR (5 each/pack, 40 pack/case) - Model Number 407; 5. Lap 12X12 XR (5 each/pack, 40 pack/case) - Model Number 411; 6. Lap 12X12 XR w/ring (5 each/pack, 40 pack/case) - Model Number 412; 7. Lap 8X36 XR (5 each/pack, 40 pack/case) - Model Number 419; 8. Lap 17X26 XR (5 each/pack, 20 pack/case) - Model Number 426;
FDA Enforcement
Class II
·Terminated·Medical Action Industries Inc·April 3, 2019