Home › Device types › EHD
Unit, X-Ray, Extraoral With Timer
FDA product code EHD · Class 2 · Dental
1,009
Registered devices
521
Adverse events
18
Recalls
191
510(k) clearances
Devices with this code
Midmark PREVA IntraOral Dental X-ray System — MIDMARK CORPORATIONSchick AE — SIRONA DENTAL, INC.CS 2100 — CARESTREAM HEALTH, INC.X-MIND unity — DE GÖTZEN SRLMidmark VETPRO IntraOral Dental X-ray System — MIDMARK CORPORATIONPOSKOM Co., Ltd. — Poskom Co., Ltd.Stern Weber — CEFLA SOCIETA' COOPERATIVAMidmark PREVA IntraOral Dental X-ray System — MIDMARK CORPORATIONFONA STELLARIS — SIRONA DENTAL, INC.Schick AE — SIRONA DENTAL, INC.FONA ELITE — SIRONA DENTAL, INC.DURAY — Beyes Dental Canada IncINTRASKAN DC — ImageWorksSCHICK ELITE — SIRONA DENTAL, INC.FONA ELITE — SIRONA DENTAL, INC.XIOS AE — SIRONA DENTAL, INC.NOMAD™ handheld X-ray system — ARIBEX, INC.Dental X-Ray Company — DENTAL XRAY COMPANY SRLOwandy-RX DC — OWANDY RADIOLOGYMidmark PREVA IntraOral Dental X-ray System — MIDMARK CORPORATIONMidmark PREVA IntraOral Dental X-ray System — MIDMARK CORPORATIONMidmark PREVA IntraOral Dental X-ray System — MIDMARK CORPORATIONFONA STELLARIS — SIRONA DENTAL, INC.Midmark PREVA IntraOral Dental X-ray System — MIDMARK CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-19 | DIGIMED CO., LTD | Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm. |
| 2017-07-14 | Panoramic Rental Corp. | The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule. |
| 2016-08-19 | Panoramic Rental Corp. | Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffecti |
| 2016-07-18 | Aribex Inc | Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Inves |
| 2016-07-18 | Aribex Inc | Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Inves |
| 2015-06-04 | Panoramic Rental Corp. | Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury. |
| 2014-08-12 | Gendex Corp | Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated ar |
| 2014-01-24 | Carestream Health Inc. | Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. |
| 2014-01-24 | Carestream Health Inc. | Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. |
| 2014-01-14 | Instrumentarium Dental, PaloDEx Group Oy | Instrumentarium Dental has delivered a number of FOCUS 3.0 Intraoral X-ray units in November 2013 with a potential flaw in the mounting hardware. A number of wa |
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