FDA 510(k) Applications Submitted by Susan Lin
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K971045 |
03/21/1997 |
BASIS FLEXIBLE TIP DIGITAL THERMOMETER |
POLYMEDICA INDUSTRIES, INC. |
| K010960 |
03/30/2001 |
EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 |
SYVA CO., DADE BEHRING, INC. |
| K011161 |
04/16/2001 |
MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 |
SYVA CO., DADE BEHRING, INC. |
| K011162 |
04/16/2001 |
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY |
SYVA CO., DADE BEHRING, INC. |
| K011163 |
04/16/2001 |
MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 |
SYVA CO., DADE BEHRING, INC. |
| K011289 |
04/27/2001 |
EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 |
SYVA CO., DADE BEHRING, INC. |
| K011347 |
05/02/2001 |
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 |
SYVA CO. |
| K011528 |
05/17/2001 |
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 |
SYVA CO. |
| K011605 |
05/24/2001 |
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 |
SYVA CO., DADE BEHRING, INC. |
| K100485 |
02/19/2010 |
GYNECARE TVT EXACT CONTINENCE SYSTEM |
ETHICON, INC. |
| K150906 |
04/03/2015 |
ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh |
EHICON INC. |
| K100936 |
04/05/2010 |
GYNECARE TVT ABBREVO CONTINENCE SYSTEM |
ETHICON, INC. |
| K141560 |
06/12/2014 |
ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE |
ETHICON, INC. |
| K132054 |
07/03/2013 |
GYNECARE TVT EXACT CONTINENCE SYSTEM |
ETHICON, INC. |
| K142822 |
09/30/2014 |
PLIASURE Polyglycolide Synthetic Absorbable Suture |
ETHICON, Inc. |
| K123114 |
10/03/2012 |
ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE |
ETHICON, INC. |
| K130943 |
04/04/2013 |
AIGIS RX R PM/ AIGIS RX R ICD |
TYRX , INC. |
| K131007 |
04/11/2013 |
AIGIS RX N MEDIUM; AIGIS RX N LARGE |
TYRX ,INC |
| K071518 |
06/04/2007 |
DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS |
B. BRAUN MEDIZINTECHNOLOGIE GMBH |
| K092313 |
07/30/2009 |
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM |
B. BRAUN MEDICAL, INC. |
| K011878 |
06/15/2001 |
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL |
SYVA CO. |
| K011920 |
06/20/2001 |
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 |
SYVA CO., DADE BEHRING, INC. |
| K011947 |
06/21/2001 |
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL |
SYVA CO. |
| K012257 |
07/18/2001 |
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 |
SYVA CO. |
| K100283 |
02/01/2010 |
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC |
COOK, INC. |
| K120468 |
02/16/2012 |
NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR |
COOK INCORPORATED |
| K130444 |
02/21/2013 |
H-30 HOLMIUM LASER SYSTEM |
COOK, INC. |
| K090624 |
03/09/2009 |
COOK MREYE EMBOLIZATION COILS |
COOK, INC. |
| K100974 |
04/08/2010 |
SPECTRUM TURBO-JECT PICC SET |
COOK INCORPORATED |
| K081113 |
04/18/2008 |
COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS |
COOK, INC. |
| K211238 |
04/26/2021 |
SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement |
Stryker Instruments |
| K081768 |
06/20/2008 |
COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES |
COOK INCORPORATED |
| K072148 |
08/03/2007 |
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER |
COOK, INC. |
| K172367 |
08/04/2017 |
Stryker Integrated Bipolar Cord and Tubing Sets |
Stryker Instruments |
| K093469 |
11/06/2009 |
CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS |
COOK, INC. |
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