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

Beaverton, OR, US

Acu Med, Inc. appears in FDA device records in Beaverton, OR. FDA records list 48 510(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
48
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 48 510(k) clearances for Acu Med, Inc. between 1990 and 2002. The busiest year on record is 1994, with 11. The most recent is 2002, with 1.

Clearances by year, as a table
510(k) clearance decisions for Acu Med, Inc., by decision year
YearClearances
19901
19912
19925
19931
199411
199511
19969
19972
19981
20002
20012
20021
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K021321WRIST FUSION PLATEHRSSubstantially Equivalent
K013616POLARUS CAP SCREWHSBSubstantially Equivalent
K012655CONGRUENT BONE PLATE SYSTEMHRSSubstantially Equivalent
K992525ACUMED MODULAR SHOULDER SYSTEMHSDSubstantially Equivalent
K993657ACUMED SUTURE ANCHORMBISubstantially Equivalent
K980103ACUMED SUTURE ANCHORMBISubstantially Equivalent
K965028ACUMED SUTURE WASHERHTNSubstantially Equivalent
K965029STABLELOC II EXTERNAL FIXATORJECSubstantially Equivalent
K964500ACUMED TENSION BAND PINHTYSubstantially Equivalent
K963026TBDHSBSubstantially Equivalent
K963118EXTREMITY BONE SCREWHWCSubstantially Equivalent for Some Indications
K963077TBDHSBSubstantially Equivalent
K962091POLARUS AF RODHSBSubstantially Equivalent
K960769ACUPUNCTURE NEEDLE PACKMQXSubstantially Equivalent
K960711ACUMED BONE GRAFT SYSTEMKIJSubstantially Equivalent
K960651CERCLAGE WIRE CRIMP BLOCKJDQSubstantially Equivalent
K954148SUTURE WASHERHTNSubstantially Equivalent
K952330EXTERNAL FIXATORJECSubstantially Equivalent
K951740INTRAMEDULARY FIXATION RODHSBSubstantially Equivalent
K950864GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)LZJSubstantially Equivalent
K952534TENTATIVELY POLARUS EX RODHSBSubstantially Equivalent
K943855BONE FIXATION NAILJDSSubstantially Equivalent
K951673ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIESHSBSubstantially Equivalent
K943856FIXATION PINS/WIRESHTYSubstantially Equivalent
K944330ACUTRAK PLUS FIXATION SYSTEMHWCSubstantially Equivalent for Some Indications
K942359BONE PLATE SYSTEMHRSSubstantially Equivalent
K945027TROCHANTER MESHEZXSubstantially Equivalent for Some Indications
K943857EXTERNAL FIXATORJECSubstantially Equivalent for Some Indications
K943782BONE SCREW WASHERHTNSubstantially Equivalent
K942787BONE ANCHORJDRSubstantially Equivalent
K942341CANNULATED CANCELLOUS BONE SCREWHWCSubstantially Equivalent for Some Indications
K942340CORTICAL BONE SCREWHWCSubstantially Equivalent for Some Indications
K942603ORTHOPAEDIC WIRESLRNSubstantially Equivalent
K932099ACUMED FLEXIBLE CANNULAHRXSubstantially Equivalent
K933638ACUMED CARPAL TUNNEL RELEASE KITHRXSubstantially Equivalent
K932027OREGON FIXATION SYSTEM INTERFERENCE SCREWHWCSubstantially Equivalent for Some Indications
K933361ACUMED RADIUS RODHSBSubstantially Equivalent
K931246CERCLAGE WIRE CRIMP SLEEVEJDQSubstantially Equivalent
K931244BONE PLATEHRSSubstantially Equivalent
K930834ACUTRACTHWCSubstantially Equivalent
K920666INTRAMEDULARY FIXATION RODHSBSubstantially Equivalent
K921480OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEMJDQSubstantially Equivalent
K920667GREAT TOE IMPLANTLZJSubstantially Equivalent
K915613BONE SCREW 3.5 MMHWCSubstantially Equivalent for Some Indications
K910976OREGON FIXATION SCREWHWCSubstantially Equivalent
K910193HUENE FIXATION SCREWHWCSubstantially Equivalent for Some Indications
K910186WYMAN SUTURE WASHERHTNSubstantially Equivalent
K904383ACUFIT TOTAL HIPKWYSubstantially 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