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

Los Angeles, CA, US

Ceremed , Inc. appears in FDA device records in Los Angeles, CA. FDA records list 20 510(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
20
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 20 510(k) clearances for Ceremed, Inc. between 2004 and 2016. The busiest year on record is 2005, with 4. The most recent is 2016, with 2.

Clearances by year, as a table
510(k) clearance decisions for Ceremed, Inc., by decision year
YearClearances
20041
20054
20061
20071
20084
20091
20101
20111
20122
20131
20151
20162
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K161446Biopor Porous Polyethylene ImplantsGWOSubstantially Equivalent
K160988Biopor, AOC Porous Polyethylene, CereporKKYSubstantially Equivalent
K141880BIOPOR AOC POROUS POLYETHYLENE, CEREPORKKYSubstantially Equivalent
K132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAIKHJSubstantially Equivalent
K122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINKHJSubstantially Equivalent
K120220ADAPTAIN SOLUBLE IMPLANT MATERIALKHJSubstantially Equivalent
K103047CERETENE SOLUBLE IMPLANT MATERIALKHJSubstantially Equivalent
K102071OSTENE CT, AOC CT, OSTEOTENE, CERETENEMTJSubstantially Equivalent
K091636OSTENE CT, AOC CT, OSTEOTENE, CERETENEMTJSubstantially Equivalent
K082491OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENEMTJSubstantially Equivalent
K082245AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LVKHJSubstantially Equivalent
K081531AOC SOLUBLE IMPLANT MATERIALKHJSubstantially Equivalent
K080507AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANTKKYSubstantially Equivalent
K070093OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTEKHJSubstantially Equivalent
K062280OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTEKHJSubstantially Equivalent
K052528AOC BONE WAX OSTENE, OSTEOTENE AND CERETENEMTJSubstantially Equivalent
K051293CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEMJEYSubstantially Equivalent
K050440AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12MTJSubstantially Equivalent
K043133AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPORKKYSubstantially Equivalent
K041363AOC BONE WAXMTJSubstantially 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

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