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

Shelton, CO, US

Emerge Medical appears in FDA device records in Shelton, CO. FDA records list 11 510(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
11
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 11 510(k) clearances for Emerge Medical between 2010 and 2014. The busiest year on record is 2014, with 8. The most recent is 2014, with 8.

Clearances by year, as a table
510(k) clearance decisions for Emerge Medical, by decision year
YearClearances
20101
20121
20131
20148
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K141347EMERGE MEDICAL IM NAIL SYSTEMHSBSubstantially Equivalent
K140675EMERGE EXTERNAL FIXATION SYSTEMKTTSubstantially Equivalent
K140107EMERGE MEDICAL DISTAL RADIUS SETHRSSubstantially Equivalent
K140119EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEMHRSSubstantially Equivalent
K140098EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEMHRSSubstantially Equivalent
K133536EMERGE MEDICAL BONE PLATE SYSTEMHRSSubstantially Equivalent
K133541EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEMHRSSubstantially Equivalent
K133452EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEMHRSSubstantially Equivalent
K131480EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEMHRSSubstantially Equivalent
K122489EMERGE MEDICAL SOLID BONE SCREWSHWCSubstantially Equivalent
K102343EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEMHWCSubstantially 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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What MDM checks, and what it does not

MDM coverage

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Claiming lets Emerge Medical edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

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