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32,815 FDA 510(k) clearances · Device class
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| Record | Firm | Date |
|---|---|---|
| LIPASE REAGENT SYSTEM (K940457) | Medical Diagnostic Technologies, Inc. | 1994-06-02 |
| APOLIPOPROTIEN B (APO B) (K932603) | Sigma Diagnostics, Inc. | 1994-06-02 |
| ACCESS PROLACTIN (K941175) | Bio-Rad Laboratories, Inc. | 1994-06-02 |
| APOLIPOPROTIEN A-1 (APO A-1) (K932606) | Sigma Diagnostics, Inc. | 1994-06-02 |
| SBP DENTAL UNIT (K934436) | Northland Dental Engineering | 1994-06-02 |
| ORION SUCTION CATHETER KIT WITH STERILE SALINE (K942274) | Regulatory & Marketing Services, Inc. | 1994-06-02 |
| ORION SUCTION CATHETER KIT WITH STERILE WATER (K942273) | Regulatory & Marketing Services, Inc. | 1994-06-02 |
| HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER (K940269) | Hollister, Inc. | 1994-06-02 |
| KIT PAK INCONTINENT SKIN CARE KIT (K932310) | Kit Pak, Inc. | 1994-06-01 |
| NOVAGEL SILICONE GEL SHEETING (K941125) | Brennen Medical, Inc. | 1994-05-31 |
| ULTRAFREE-CL (K941326) | Millipore Corp. | 1994-05-27 |
| LORREX GAUZE SPONGES, X-RAY DETECTABLE (K942366) | Lorrex Health Products | 1994-05-27 |
| REBREATHER BAGS (K940220) | Zefon Medical Products | 1994-05-27 |
| MOLYBDENUM/RHODIUM FILTERS (K934686) | Continental X-Ray Corp. | 1994-05-26 |
| PATIENT EXAMINATION GLOVES (K940576) | Vijay Latex Products Private , Ltd. | 1994-05-26 |
| VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM (K931816) | Calgon Vestal Div. | 1994-05-26 |
| THERMAPOST ENDODONTIC ROOT CANAL POST (K922931) | Tulsa Dental Products, Ltd. | 1994-05-26 |
| ALDEN WHEELCHAIR CUSHION (K942260) | Ward and Assoc. | 1994-05-26 |
| LPH (K931342) | Calgon Vestal Div. | 1994-05-26 |
| FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY (K933767) | Mahe-Medizintechnik | 1994-05-26 |
| LATEX PATIENT EXAMINATION GLOVE (K940022) | Siam Sempermed Corp., Ltd. | 1994-05-26 |
| WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT (K940288) | Teledyne Water Pik | 1994-05-26 |
| ALDEN LINEAGE WHEELCHAIR CUSHION (K942312) | Lewis W. Ward | 1994-05-26 |
| FEMININE MAXI PADS (K940468) | B.A. Wholesale, Inc. | 1994-05-26 |
| URETERAL CATHETER AND ACCESSORIES (K934419) | Urological Associates of Central Jersey P.A. | 1994-05-25 |
| OWENS BIOPSY FORCEPS (K926595) | Owens Industries, Inc. | 1994-05-25 |
| TRACH TIE, VENTILATOR TUBING HOLDER (K942016) | Garrett Medical Products | 1994-05-24 |
| SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY (K941497) | Solarcare, Inc. | 1994-05-24 |
| AUTO DELFIA (K935047) | Wallac OY | 1994-05-23 |
| 3M 1156 MULTI-INPUT SYSTEM (K936153) | 3M Information,Imaging and Electronic Sector | 1994-05-23 |
| CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF (K940810) | Ciba Corning Diagnostics Corp. | 1994-05-23 |
| THE EXPANDACELL EAR PACK (K940133) | Denver Splint Co. | 1994-05-23 |
| HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING (K941216) | Wilshire Medical Products | 1994-05-20 |
| BACTICARD STREP (K936021) | Remel Co. | 1994-05-20 |
| WATSYSTEM (K926136) | Watsystem Div. of Itc | 1994-05-20 |
| MICROFLOW IRRIGATION SYSTEM (K941356) | Jedmed Instrument Co. | 1994-05-19 |
| COMFIT POWERED EXAMINATION GLOVES(BEADED, HYPOALLERG) (K935866) | Wembley Rubber Products (M) Sdn Bhd | 1994-05-18 |
| TAP EXPRESS EJECTOR (K941164) | Tap Express, Inc. | 1994-05-18 |
| NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE (K932404) | Safeskin Corp. | 1994-05-18 |
| NON-PRESCRIPTION SUNGLASSES (K940958) | Great Future Works , Ltd. | 1994-05-18 |
| NITINOL, NITI (K935638) | Highland Metals | 1994-05-18 |
| MON-KLENZ (K941163) | Calgon Vestal Div. | 1994-05-18 |
| URINARY DRAINAGE BAG (K934080) | Kit Pak, Inc. | 1994-05-18 |
| NPH-KLENZ (K940263) | Calgon Corp. | 1994-05-18 |
| SONIPLAK (K935150) | American Dentronics, Inc. | 1994-05-18 |
| RETRO MIRROR (K941574) | Union Broach, Div. Moyco Industries, Inc. | 1994-05-18 |
| NITRILE RUBBER EXAMINATION GLOVES (POWERED) (K932405) | Safeskin Corp. | 1994-05-18 |
| FLEXSURE HP (K934863) | Smithkline Diagnostics, Inc. | 1994-05-18 |
| BORRION ENTERPRISE CO (K941340) | Borrion Enterprise Co. | 1994-05-17 |
| SUNGLASSES (K941732) | Pacific Eyes & T'S | 1994-05-17 |
| SUNGLASSES (K941786) | Modo Eyewear USA | 1994-05-17 |
| SUNGLASSES (K941590) | Avon Products, Inc. | 1994-05-17 |
| COOL KIDS BEADS AND SHADES (K941682) | Ja-Ru, Inc. | 1994-05-17 |
| 86 HQY SUNGLASSES (K940705) | Firestar, Inc. | 1994-05-17 |
| ALPINA EYEWEAR (K941060) | Alpina High Tech Sports Eyewear | 1994-05-17 |
| CHIN HSIEU CHENG (K941410) | Large River Industrial Co., Ltd. | 1994-05-17 |
| SPECTACLE FRAMES (K941523) | Amore Mio, Inc. | 1994-05-17 |
| SUNGLASSES (K941502) | Asia Pacific Trading Co., Inc. | 1994-05-17 |
| CHANG CHENG CHUNG (K941338) | Designer Brass Corp. | 1994-05-17 |
| SUNGLASS (K934659) | South American Plastic Manufactory Co. , Ltd. | 1994-05-17 |
| NON-PRESCRIPTION SUNGLASSES (K941186) | Sungold Ent. , Ltd. | 1994-05-17 |
| SUNLOVERS, CHARLES JOURDAN, COURREGES SUNGLASSES (K935422) | Sunlovers Sunglasses | 1994-05-17 |
| SPECTACLE FRAMES (K940504) | Tecnol-Tecnica Nacional DE Oculos Ltda | 1994-05-17 |
| SUNGLASSES (K941638) | Sun Coast Merchandise Corp. | 1994-05-17 |
| SUNGLASSES (K940943) | Kendward Industrial Corp. | 1994-05-17 |
| READER (K926248) | Alamar Biosciences Laboratory, Inc. | 1994-05-17 |
| RETRACTOR (K942002) | Automated Medical Products Corp. | 1994-05-17 |
| SUNGLASSES (NON PRESCRIPTION) (K941280) | Autotime Industry, Inc. | 1994-05-17 |
| SUNGLASSES (K941930) | Sunvista Import, Inc. | 1994-05-17 |
| SUNGLASSES (K941668) | Yon'S Jay Enterprise Co., Ltd. | 1994-05-17 |
| SUNGLASSES (K941380) | Spare Parts Accessories | 1994-05-17 |
| PARAKIT (K941110) | Hardy Diagnostics | 1994-05-17 |
| LIPASE-PS ASSAY PROCEDURE NO. 805 (K941085) | Sigma Diagnostics, Inc. | 1994-05-17 |
| SUNGLASSES (K941629) | Kuang Yauh Optical Co., Ltd. | 1994-05-17 |
| AVON CAT SUNGLASSES (K941369) | Siegel,Mandell & Davidson,P.C. | 1994-05-17 |
| SUN FILTERS/SHIELDS (K941829) | Klinger Eye Shields, Inc. | 1994-05-17 |
| SUNGLASSES AND SPORT SUNGLASSES (K940311) | Lanner Enterprise Co., Ltd. | 1994-05-17 |
| NONE-GENERIC (K940728) | Dyer Intl. | 1994-05-17 |
| SPECTACLE FRAMES (K941307) | Eyemart Express, Inc. | 1994-05-17 |
| SUNGLASSES (K940945) | Hi-Shine Ent. Co., Ltd. | 1994-05-17 |
| TOUCH CORP (K940609) | Touch Corp. | 1994-05-17 |
| PERIOFLEX TIP (K923711) | Novadent, Ltd. | 1994-05-16 |
| VESPHENE II (K931573) | Calgon Vestal Div. | 1994-05-16 |
| VENOSCOPE (K941035) | Trinity Partners, LLC | 1994-05-16 |
| KAVO INTRASEPT 905 (K934783) | Kavo America | 1994-05-16 |
| DISPOSABLE PROPHYLAXIS ANGLE (K941189) | Team Technologies, Inc. | 1994-05-16 |
| SURESOFT SURGICAL GLOVES (K940218) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-05-16 |
| GRIDGIL (K941626) | Gilardoni S.P.A. | 1994-05-13 |
| PHONAK SONO-FORTE 331X BTE HEARING INSTRUMENTS (K941734) | Phonak, Inc. | 1994-05-13 |
| PRO-CONNECT (K932269) | Starkey Laboratories, Inc. | 1994-05-13 |
| WAX GUARD OPTION (K941039) | Miracle-Ear, Inc. | 1994-05-12 |
| AUDIOTONE MODEL A-54 (K941121) | Miracle-Ear, Inc. | 1994-05-12 |
| SHARP II SEMI CONTOUR HEARING AID (K941293) | Miracle-Ear, Inc. | 1994-05-12 |
| THE EXPANDACELL SINUS PACK (K935724) | Denver Splint Co. | 1994-05-12 |
| SHARP II LOW PROFILE HEARING AID (K941294) | Miracle-Ear, Inc. | 1994-05-12 |
| LONZA FORMULATION R-82 (K932502) | Lonza, Inc. | 1994-05-12 |
| LAP SPONGE PRODUCT LINE (K941344) | Cush Medical Products | 1994-05-12 |
| LONZA FORMULATION R-82 (K932277) | Calgon Vestal Div. | 1994-05-12 |
| MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST (K933811) | Pitt Enterprises (Silicone) , Ltd. | 1994-05-12 |
| AUDIOTONE MODEL A-54SR (K941122) | Miracle-Ear, Inc. | 1994-05-12 |
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Every clearance here is in the API, with alerts when new ones post.