510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Rex Medical LP

Conshohocken, PA, US

REX MEDICAL LP appears in FDA device records in Conshohocken, PA. FDA records list 21 510(k) clearances between and , 7 PMA records and one registered establishment. 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
21
PMA records
7
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 21 510(k) clearances for Rex Medical LP between 2003 and 2021. The busiest year on record is 2003, with 5. The most recent is 2021, with 1.

Clearances by year, as a table
510(k) clearance decisions for Rex Medical LP, by decision year
YearClearances
20035
20042
20051
20061
20071
20091
20102
20122
20131
20141
20151
20181
20191
20211
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K212351Revolution Peripheral Atherectomy SystemMCWSubstantially Equivalent
K191419Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy GuidewireMCWSubstantially Equivalent
K173389Rex Medical Aspiration PumpBTASubstantially Equivalent
K143405Option (TM) ELITE Vena Cava Filter 100cm SystemDTKSubstantially Equivalent
K141617CLEANER ROTATIONAL THROMBECTOMY SYSTEMQEWSubstantially Equivalent
K133243OPTION ELITE VENA CAVA FILTER SYSTEMDTKSubstantially Equivalent
K120346CLEANER ROTATIONAL THROMBECTOMY SYSTEMMCWSubstantially Equivalent
K113103SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICEPNOSubstantially Equivalent
K102043ULTRASTREAM CHRONIC HEMODIALYSIS CATHETERMSDSubstantially Equivalent
K091029CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)MCWSubstantially Equivalent
K081410OPTION VENA CAVA FILTERDTKSubstantially Equivalent
K07142215.5F HEMO-STREAM HEMODIALYSIS CATHETER SETMSDUnknown
K060904CLEANER ROTATIONAL THROMBECTOMY SYSTEMMCWSubstantially Equivalent
K051468INNER-LOCK INTRODUCER SHEATHDYBSubstantially Equivalent
K042399MODIFICATION TO SHORT INTRODUCER SHEATHDYBSubstantially Equivalent
K040252CLEANER ROTATIONAL THROMBECTOMY SYSTEM KITMCWSubstantially Equivalent
K033793CLEANER II ROTATIONAL THROMBECTOMY SYSTEMMCWSubstantially Equivalent
K032569SHORT INTRODUCER SHEATHDYBSubstantially Equivalent
K031610REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEMMCWSubstantially Equivalent
K023847HEMO-STREAM HEMODIALYSIS CATHETER SETMSDUnknown
K022170INNER-LOCK LOCKING INTRODUCER SHEATHSDYBSubstantially Equivalent

Registered establishments

FDA registered establishments for Rex Medical LP, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30038626573003862657REX MEDICAL LP1100 E Hector St Ste 396, CONSHOHOCKEN, PA 19428 US2026

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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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