510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MRIMed Inc. dba: Quality Safety Tools

Petaluma, CA, US

MRIMed Inc. DBA: Quality Safety Tools appears in FDA device records in Petaluma, CA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
0
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to MRIMed Inc. dba: Quality Safety Tools carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • MRIMed Inc.enforcement report, recall

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for MRIMed Inc. dba: Quality Safety Tools, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30095608913009560891MRIMed Inc. DBA: Quality Safety Tools1320 Stub Rd, Petaluma, CA 94954 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1436-2026MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam LightDue to battery component overheating while charging resulting in melting of internal components and causing smoke.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain