| SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR (K010309) | Mutoh America Co., Ltd. | 2001-04-18 |
| TCOYF FERTILITY SOFTWARE VERSION 1.0 (K002726) | Ovusoft, LLC | 2001-04-06 |
| AT HOME DRUG TESTT, MODEL 9150 T (K010655) | Phamatech | 2001-04-05 |
| AT HOME DRUG TEST, MODEL 9078 T (K010654) | Phamatech | 2001-04-05 |
| AT HOME DRUG TEST, MODEL 9068 T (K010653) | Phamatech | 2001-04-05 |
| AT HOME DRUG TEST, MODEL 9083 T (K010646) | Phamatech | 2001-03-30 |
| AT HOME DRUG TEST, MODEL 9133 T (K010651) | Phamatech | 2001-03-30 |
| ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING (K004028) | Maersk Medical, Ltd. | 2001-03-27 |
| FS ACTIVATOR III (K003185) | Activator Methods International, Ltd. | 2001-03-20 |
| MODIFICATION TO ACTICOAT FOAM DRESSING (K010447) | Westaim Biomedical, Inc. | 2001-03-15 |
| ULTRAPAK NEHA (K010070) | Ultradent Products, Inc. | 2001-03-15 |
| OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI (K003824) | Omnisonics Medical Technologies | 2001-03-08 |
| DIAMOND ALOE VERA, STERILE (K002666) | Medi-Tech Intl. Corp. | 2001-02-27 |
| ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING (K002896) | The Westaim Corp. | 2001-02-21 |
| ACTICOAT COMPOSITE DRESSING (K002466) | Westaim Biomedical, Inc. | 2001-02-16 |
| GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 (K002596) | Gebauer Co. | 2001-02-15 |
| MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 (K003858) | Phamatech | 2001-02-12 |
| GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 (K001624) | Gebauer Co. | 2001-01-25 |
| EDTA ROOT CANAL CLEANSER (K003422) | Super Glide, Inc. | 2001-01-19 |
| TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM (K003928) | Medtronic Sofamor Danek, Inc. | 2001-01-17 |
| BURN JEL PLUS (K003396) | Water-Jel Technologies, LLC | 2001-01-11 |
| FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING (K003134) | Adri/Technam | 2000-12-22 |
| ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07 (K002906) | Ethicon Endo-Surgery, Inc. | 2000-12-15 |
| BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D (K002272) | Branan Medical Corp. | 2000-11-22 |
| COLLAGEN WOUND DRESSING (K002443) | Oasis Research, LLC | 2000-10-18 |
| ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103 (K002909) | Acrymed, Inc. | 2000-10-13 |
| ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4 (K000927) | Misonix, Inc. | 2000-10-10 |
| ACTICOAT 7 DRESSING (K001519) | Westaim Biomedical, Inc. | 2000-10-06 |
| BETA GLUCAN GEL (MACROPRO GEL) (K002078) | Brennen Medical, Inc. | 2000-10-02 |
| GLUCANPRO CREAM (K002077) | Brennen Medical, Inc. | 2000-10-02 |
| MODIFICATION TO PROFILE -II (K002776) | Medtox Diagnostics, Inc. | 2000-09-28 |
| OLYMPUS SONOSURG TROCAR XT3900 SYSTEM (K000095) | The Olympus Optical Co. | 2000-09-26 |
| FREEDOM, MODEL 4660 (K001023) | Johnson & Johnson Consumer Companies, Inc. | 2000-09-22 |
| MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 (K002599) | Acrymed, Inc. | 2000-09-21 |
| OCCU-FLO PUNCTUM PLUGS (K001768) | U.S. Iol, Inc. | 2000-09-19 |
| FORAMATRON V, MODEL D680 (K002195) | Parkell, Inc. | 2000-08-30 |
| FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN (K002129) | Ferris Mfg. Corp. | 2000-08-25 |
| TORQUE INSTRUMENT, MODEL 8500 (K001476) | Spinalight, Inc. | 2000-08-04 |
| NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW (K001323) | Nuvasive, Inc. | 2000-07-25 |
| BIOINSULATED SILICONE PUNCTUM PLUG (K001234) | Advanced Vision Science | 2000-07-11 |
| OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM (K001737) | Lacrimedics, Inc. | 2000-06-19 |
| ACTICOAT PRIMARY ANTIMICROBIAL DRESSING (K992221) | Westaim Biomedical, Inc. | 2000-06-07 |
| STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 (K000399) | OraSure Technologies, Inc. | 2000-05-15 |
| GLUCANPRO (K000519) | Brennen Medical, Inc. | 2000-05-01 |
| MACROPRO GEL (K000518) | Brennen Medical, Inc. | 2000-05-01 |
| NUVASIVE TOWNLEY FACET SCREW (K994308) | Nuvasive, Inc. | 2000-04-18 |
| MEDTRADE PRODUCTS ALGINATE ISLAND (K000487) | Medtrade Products , Ltd. | 2000-04-18 |
| SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST (K000402) | Drug Detection Devices, Ltd. | 2000-04-18 |
| ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 (K991818) | Acrymed, Inc. | 2000-04-17 |
| MEDLINE TENDER WET WOUND DRESSING (K991755) | Medline Industries, Inc. | 2000-04-17 |
| DIGITAL INFLECTION RIGIDOMETER (DIR) (K000194) | Uroan Xxi Electromedicina | 2000-04-10 |
| URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A (K000462) | Dade Behring, Inc. | 2000-04-06 |
| ACTICOAT FOAM DRESSING (K000051) | Westaim Biomedical, Inc. | 2000-04-05 |
| AESCULAP BONE WAX (K000021) | Aesculap, Inc. | 2000-03-24 |
| HYCURE ORAL / HYCURE ORAL SMART GEL (K994339) | The Hymed Group Corp. | 2000-03-22 |
| ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105 (K994280) | Ethicon Endo-Surgery, Inc. | 2000-03-17 |
| FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN (K000054) | Adri | 2000-03-13 |
| ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 (K994020) | Roche Diagnostics Corp. | 2000-01-27 |
| ONTRAK TESTCUP 5, CAT. 07 6481 7 (K994030) | Roche Diagnostics Corp. | 2000-01-27 |
| ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1 (K994017) | Roche Diagnostics Corp. | 2000-01-27 |
| SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL (K993983) | Syva Co. | 2000-01-27 |
| DERMAFREEZE (K992286) | Rhealm Pharmaceuticals, Inc. | 2000-01-21 |
| SIS WOUND DRESSING II (K993948) | Cook Biotech, Inc. | 2000-01-06 |
| AT HOME DRUG TEST, MODEL 9133 (K994236) | Phamatech | 1999-12-30 |
| SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION (K993969) | Winchester Laboratories, LLC | 1999-12-30 |
| MPM REGENECARE WOUND GEL (K992074) | Mpm Medical., Inc. | 1999-12-23 |
| FASTSEAL CHEST WOUND DRESSING (K990079) | Greenfield Medical Technologies, Inc. | 1999-12-23 |
| THE SOUNDVASER DISSECTION SYSTEM (K993868) | Sound Surgical Technologies, LLC | 1999-12-21 |
| AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C (K994093) | Phamatech | 1999-12-16 |
| OMNISONICS ULTRASONIC PROBES (K993628) | Omnisonics Medical Technologies | 1999-12-15 |
| DRUG STOP (K991465) | Texas Immunology, Inc. | 1999-12-10 |
| ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141 (K993054) | Ethicon Endo-Surgery, Inc. | 1999-12-09 |
| BIONIKE AQ PHENCYCLIDINE (PCP) TEST (K993945) | Bionike Laboratories, Inc. | 1999-12-07 |
| ETHYL CHLORIDE DISPENSER (K984564) | Dukal Corp. | 1999-12-02 |
| APEX LOCATOR BINGO-1020 (K992233) | Dent Corp. Research & Development | 1999-11-30 |
| STERILE HYDROGEL (K993119) | Dumex Medical Surgical Products, Ltd. | 1999-11-23 |
| OXY-GLIDE ROOT CANAL CLEANSER & LUB. (K992919) | Super Glide, Inc. | 1999-11-19 |
| ANTIBACTERIAL ADHESIVE BANDAGE (K992817) | William Feinstein & Associates, Inc. | 1999-11-05 |
| RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG (K992484) | Jordco, Inc. | 1999-10-14 |
| SIMPLICARE TRANSPARENT WOUND DRESSING (K991214) | Hollister, Inc. | 1999-10-14 |
| QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C (K992685) | Phamatech | 1999-10-06 |
| SILVERLON WOUND PACKING STRIPS (K984210) | Argentum International, LLC | 1999-09-24 |
| ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING (K990810) | Maersk Medical, Ltd. | 1999-09-17 |
| DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (K992302) | Dermaphylyx, Inc. | 1999-09-14 |
| GILTECH PLUS TRANSPARENT DRESSING (K992005) | Giltech Plus, Inc. | 1999-09-03 |
| ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 (K990689) | Zcv ,Inc. | 1999-09-03 |
| REDI-TEST PCP (K991698) | Redwood Biotech, Inc. | 1999-08-25 |
| BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD (K990179) | Nortrade Medical, Inc. | 1999-08-13 |
| BURNFREE PAIN RELIEVING GEL, MODEL 4B (K990178) | Nortrade Medical, Inc. | 1999-08-13 |
| BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING (K990180) | Nortrade Medical, Inc. | 1999-08-13 |
| GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE (K990440) | Gentell | 1999-08-12 |
| SOUND VASER SYSTEM (K991791) | Sound Surgical Technologies, LLC | 1999-08-12 |
| NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (K991757) | Furlong Industries | 1999-08-12 |
| SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN (K992363) | Euromed, Inc. | 1999-08-12 |
| CAPHOSOL ARTIFICIAL SALIVA (K991938) | Inpharma A.S. | 1999-08-10 |
| MICRO-STRIP FOR PHENCYCLIDINE METABOLITES (K991505) | Microdiagnostics, Inc. | 1999-08-05 |
| GEBAUER'S CHLORIDE FINE NOZZE (K991514) | Gebauer Co. | 1999-07-16 |
| AT HOME DRUG TEST, MODEL 9175 (K992217) | Phamatech | 1999-07-13 |
| FCI CRAWFORD PROBE INTUBATION SETS (K991238) | Fci Ophthalmics, Inc. | 1999-07-08 |
| VISER PENILE TUMESCENCE MONITOR (K991479) | Laborie Medical Tech Corp. | 1999-07-07 |