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Rapid Medical Inc.

yokneam Northern, IL

RAPID MEDICAL INC. appears in FDA device records in yokneam Northern, IL. FDA records list 10 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
10
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 10 510(k) clearances for Rapid Medical Inc. between 2019 and 2026. The busiest year on record is 2024, with 2. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Rapid Medical Inc., by decision year
YearClearances
20191
20201
20211
20221
20231
20242
20251
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K254006Drivewire 35 GuidewireMOFSubstantially Equivalent
K253062Tigertriever 25 Revascularization DeviceNRYSubstantially Equivalent
K251603Tigertriever 17 Ultra Revascularization DeviceNRYSubstantially Equivalent
K233791Drivewire 24 GuidewireMOFSubstantially Equivalent
DEN230064BraidE Embolization Assist DeviceQZUUnknown
K230429Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization DeviceNRYSubstantially Equivalent
K220808Tigertriever 13 Revascularization DeviceNRYSubstantially Equivalent
K203592Tigertriever and Tigertriever 17 Revascularization DevceNRYSubstantially Equivalent
K200374Columbus GuidewireMOFSubstantially Equivalent
DEN170064Comaneci, Comaneci Petit, Comaneci 17PUUUnknown

Registered establishments

FDA registered establishments for Rapid Medical Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30155317233015531723RAPID MEDICAL INC.445 South Kimball Avenue, Southlake, TX 76092 US2026
30099579473009957947RAPID-MEDICAL LTDCarmel Building POB337, yokneam Northern 2069205 IL2026

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

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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