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

Jeffrey, NH, US

Rusch Intl. appears in FDA device records in Jeffrey, NH. FDA records list 43 510(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
43
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 43 510(k) clearances for Rusch Intl. between 1995 and 2003. The busiest year on record is 1998, with 7. The most recent is 2003, with 4.

Clearances by year, as a table
510(k) clearance decisions for Rusch Intl., by decision year
YearClearances
19954
19966
19973
19987
19994
20002
20016
20027
20034
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K033023INTERMITTENT URETHRAL CATHETERSKODSubstantially Equivalent
K030559RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEMESWSubstantially Equivalent
K023666RUSCH GUIDED CHOLANGIOGRAPHY CATHETERFGESubstantially Equivalent
K023918RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESSJOHSubstantially Equivalent
K023964RUSCH MICROLARYNGEAL TUBEBTRSubstantially Equivalent
K021540RUSCH EDGAR TUBEBTRSubstantially Equivalent
K021764RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFEDBTOSubstantially Equivalent
K020714RUSCH FLONEIL; FLOCATH INTROGELGBMSubstantially Equivalent
K010798RUSCH CANTOR TUBEKNTSubstantially Equivalent
K010797RUSCH MILLER-ABBOTT TUBEKNTSubstantially Equivalent
K013872RUSCH MEMORY BAGGCJSubstantially Equivalent
K013266RUSCH POLYFLEX STENT KITNYTSubstantially Equivalent
K010596RUSCH BRONCHUS BLOCKER KITCBISubstantially Equivalent
K011122BALLPEN SPINAL NEEDLE W/WO INTRODUCERBSPSubstantially Equivalent
K011121RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETSLJESubstantially Equivalent
K011210THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMYJOHSubstantially Equivalent
K010068RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEMESWSubstantially Equivalent
K000070FLOCATHKODSubstantially Equivalent
K993786RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHYBTRSubstantially Equivalent
K993063RUSCH BRILLANT SILICONE FOLEYEZLSubstantially Equivalent
K990619RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILEBTRSubstantially Equivalent
K982974DD URETERAL STENT, INTEGRAL STENTFADSubstantially Equivalent
K983010SELF CATH SET/SAFETY CATHFCMSubstantially Equivalent
K982614RUSCH POLYFLEX STENT KITNYTSubstantially Equivalent
K983125EPIDURAL CATHETER MODELS 1210/1200CAZSubstantially Equivalent
K981203RUSCH BLAKEMORE 3 LUMEN, STERILEKNTSubstantially Equivalent
K973892RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE)KNTSubstantially Equivalent
K972546RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SETJOHSubstantially Equivalent
K972423RUSCH TRACHEOFIX-SETJOHSubstantially Equivalent
K972184RUSCH BRILLANT SILICONE FOLEY CATHETEREZLSubstantially Equivalent
K964056RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILEJOHSubstantially Equivalent
K971643RUSCH BRILLANT BALLOON CATHETEREZLSubstantially Equivalent
K964575SYMPACATH HYDROGEL COATED FOLEYEZLSubstantially Equivalent
K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERFAPSubstantially Equivalent
K961837RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHYBTRSubstantially Equivalent
K961840RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHYBTRSubstantially Equivalent
K954585RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILEBTRSubstantially Equivalent
K960240RUSCH OPTOSAFECAESubstantially Equivalent
K955238RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLEBSRSubstantially Equivalent
K952573RUSCH URODYNAMIC RECTAL BALLOON CATHETERFENSubstantially Equivalent
K952029RUSCH INTERNATIONAL URODYNAMIC CATHETERSFENSubstantially Equivalent
K951091RUSCH ENDOBRONCHIAL TUBE SETSBTSSubstantially Equivalent
K951046RUSCH ENDOTEST CUFF PRESSURE MONITORBSKSubstantially 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