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

Colmar, PA, US

META BIOMED CO., LTD. appears in FDA device records in Colmar, PA. FDA records list 25 510(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
25
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 25 510(k) clearances for Meta Biomed Co., Ltd. between 2003 and 2024. The busiest year on record is 2008, with 3. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Meta Biomed Co., Ltd., by decision year
YearClearances
20032
20041
20061
20071
20083
20132
20142
20183
20193
20201
20212
20233
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242014Jet Flow BulkEBFSubstantially Equivalent
K232299CeraPuttyKIFSubstantially Equivalent
K230010ADSEAL PlusKIFSubstantially Equivalent
K230009EZ Bond UniversalKLESubstantially Equivalent
K210904Metapaste PlusKIFSubstantially Equivalent
K202617Metapex PlusKIFSubstantially Equivalent
K191991EzfilEBFSubstantially Equivalent
K190724MD-Temp PlusEBGSubstantially Equivalent
K190503CeraSealKIFSubstantially Equivalent
K190510GuttaSilKIFSubstantially Equivalent
K181689NexcompEBFSubstantially Equivalent
K180802Meta P&BondKLESubstantially Equivalent
K171449MetacemEMASubstantially Equivalent
K133298ENDO SMARTEKXSubstantially Equivalent
K134008MD-FLEX HEAVY BODYELWSubstantially Equivalent
K132041REXTAR XEHDSubstantially Equivalent
K122016REXTAR, REXTAR LCDEHDSubstantially Equivalent
K081913METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMEREMASubstantially Equivalent
K080772BONEMEDIK-DMLYCSubstantially Equivalent
K080305NEXCOMP AND META ETCHANTEBFSubstantially Equivalent
K070897BONEMEDIK, AND BONEMEDIK-SMQVSubstantially Equivalent
K061530MD-TEMPEBGSubstantially Equivalent
K042769ADSEAL ROOT CANAL SEALERKIFSubstantially Equivalent
K032605METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLINGKIFSubstantially Equivalent
K032603METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLINGKIFSubstantially Equivalent

Registered establishments

FDA registered establishments for Meta Biomed Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96812543005907356META BIOMED CO., LTD.270, Osongsaengmyeong 1-ro, Osong-eup,Heungdeok-gu, Cheongju-si Chungbuk 28161 KR2026and 4 more, listed in full below
30073013263007301326Meta Biomed, Inc.3015 Advance Lane, Colmar, PA 18915 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