510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Macropore Biosurgery, Inc.

San Diego, CA, US

Macropore Biosurgery, Inc. appears in FDA device records in San Diego, CA. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
17
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 17 510(k) clearances for Macropore Biosurgery, Inc. between 2000 and 2004. The busiest year on record is 2001, with 7. The most recent is 2004, with 2.

Clearances by year, as a table
510(k) clearance decisions for Macropore Biosurgery, Inc., by decision year
YearClearances
20003
20017
20021
20034
20042
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K042261MACROPORE PURICEL LIPOPLASTY SYSTEMQPBSubstantially Equivalent
K041105MACROPORE HYDROSORB SPINE SYSTEMKWQSubstantially Equivalent
K031955MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEETFTLSubstantially Equivalent
K031785MACROPORE CARDIO-WRAP (TS)OMHSubstantially Equivalent
K024169MACROPORE OS RECONSTRUCTIONEZXSubstantially Equivalent
K023643MACROPORE SURGICAL BARRIER FILMMTZSubstantially Equivalent
K021164MACROPORE OS TRAUMAHRSSubstantially Equivalent
K012025MACROPORE SURGIWRAP (TS)FTLSubstantially Equivalent
K012769MACROPORE ENT RECONSTRUCTION FILMNHBSubstantially Equivalent
K012413MACROPORE FX, PS, NS, LPJEYSubstantially Equivalent
K011715MACROPORE IB RESORBABLE PLUGJDIUnknown
K010911MACROPORE OS SPINAL SYSTEMKWQSubstantially Equivalent
K002207MACROPOREPX PEDIATRIC SYSTEMJEYSubstantially Equivalent
K002334MACROPORENS CRANILOCGXRSubstantially Equivalent
K000696MACROPOREMX MANDIBULAR FIXATION SYSTEMJEYSubstantially Equivalent
K994158MACROSORBOS PROTECTIVE SHEETHRSSubstantially Equivalent
K000992MACROPOREDX DISTRACTOR SYSTEMMQNSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

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