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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
SWEDE CROSS MANUAL WHEELCHAIR (K914610)Etac Us, Inc.1991-11-29
TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL (K914511)Technicon Instruments Corp.1991-11-27
AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT (K914906)Bio-Tek Instruments, Inc.1991-11-27
DIMENSION(R) LACTIC ACID METHOD (K914508)E.I. Dupont DE Nemours & Co., Inc.1991-11-27
OTOSONIC (OSI) LPS IN-THE-EAR HEARING AID (K914981)Beltone Electronics Corp.1991-11-27
REP(R) SPE TEMPLATE 30, 16, & 8 (K913807)Helena Laboratories1991-11-27
REFURBISHED ORTHODONTIC APPLIANCES (K913913)Ortho-Cycle Co.1991-11-27
SUAN FLAT DISSECTOR SPONGES (K914082)Icn Pharmaceuticals, Inc.1991-11-27
MICRO-X 30 HF (K914266)Fischer Imaging Corp.1991-11-27
MICRO-X 50 HF (K914236)Fischer Imaging Corp.1991-11-27
BELTONE PROFILE IN-THE-EAR HEARING AID (K914982)Beltone Electronics Corp.1991-11-27
POWDER FREE, NON-STERILE, LATEX EXAMINATION GLOVES (K914498)Medmark, Inc.1991-11-27
MEDICAL TAPE (K912623)Renfrew Tape, Ltd.1991-11-27
BARD SINGULAR BIOPSY FORCEPS (K914212)C.R. Bard, Inc.1991-11-27
OTOSONIC ACS-ASP (K914939)Beltone Electronics Corp.1991-11-22
CVM (K914619)Ciba Corning Diagnostics Corp.1991-11-22
ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33 (K914018)Em Diagnostic Systems, Inc.1991-11-22
BELTONE CLEARVOICE (K914940)Beltone Electronics Corp.1991-11-22
LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM) (K914170)Bio-Rad1991-11-22
WHEELCHARIOT LIGHTWEIGHT MANUAL WHEELCHAIR (K914785)Wheelchariots, Inc.1991-11-22
ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43 (K914464)Em Diagnostic Systems, Inc.1991-11-22
CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP (K914015)Pilling Co.1991-11-21
KLEER(TM) ORTHODONTIC BRACKET (K914616)Ormco Corp.1991-11-20
SIMPEX INC. SURGICAL DRESSING (K913794)Simpex, Inc.1991-11-20
DTF-1000LL,DTF-1000 (K911118)Cp Medical1991-11-20
ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK (K914226)E.I. Dupont DE Nemours & Co., Inc.1991-11-19
ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL (K914806)Roche Diagnostic Systems, Inc.1991-11-19
MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDS (K911111)Vermont Diamond Instruments1991-11-19
TRACE GAMMA GT-SS REAGENT (K914731)Trace Scientific , Ltd.1991-11-19
SAS RUBBER PRODUCTS CO./LATEX EXAMINATION GLOVES (K911939)Overseas Import & Export Dist.1991-11-15
DUOMAT 3 AMALGAMATOR (K914340)Degussa AG1991-11-13
SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS (K914529)Oasis Medical, Inc.1991-11-13
MDT/CASTLE PURUS DENTAL UNIT (K914697)Mdt Corp., Inc.1991-11-13
JOHNSON AND JOHNSON POWER SYSTEM (K913629)Johnson & Johnson Orthopaedics, Inc.1991-11-13
STOMAVISION (STV) (K913464)Trophy Radiologie1991-11-13
MIXOMAT AMALGAMATOR (K914341)Degussa AG1991-11-13
BACK MASTER (K914394)Progressive Electrical Therapeutics1991-11-13
PART 872 DEGUFILL H & DEGUFILL M DA (K914368)Degussa AG1991-11-13
TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM (K911734)Northland Cataract & Eye Care Clinic1991-11-07
STETHOSCOPE (K914100)Atlas Medical Products, Inc.1991-11-07
SAFETY PLUS DENTAL INJECTION NEEDLE (K913573)Specialites Septodont1991-11-07
PATIENT EXAMINATION GLOVES (K913776)P.T. Irama Dinamika Latex1991-11-07
DENTOMAT 3 AMALGAMATORS (K914339)Degussa AG1991-11-07
TRIGLYCERIDES REAGENT SET (K914609)Sterling Diagnostics, Inc.1991-11-07
ROCKET SURGICAL SKIN MARKING PEN (K912730)West Texas Lighthouse For the Blind1991-11-07
PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF (K914628)Medical Resources, Ltd.1991-11-07
OPUS(R) LH TEST SYSTEM (K913938)Pb Diagnostic Systems, Inc.1991-11-07
OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR (K913559)Osteo AG1991-11-07
P54 BTE HEARING AID (K914800)Philips Hearing Instruments Co.1991-11-05
HEARING AID, UNITRON MODEL VISTA 4000 (K914689)Unitron Industries, Inc.1991-11-05
AUTOMATIC CORNEAL SHAPER (K913697)Hansa Research & Development, Inc.1991-11-05
IN-THE-EAR HEARING AIDS (K913366)Fenwick Hearing Instruments1991-11-05
MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR (K913577)Control-X, Inc.1991-11-05
STAYFREE(TM) MAXI-PAD (K913747)Personal Products Co.1991-11-05
ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32 (K913764)Em Diagnostic Systems, Inc.1991-11-05
HEARING AID, UNITRON MODEL VISTA 3000 (K914688)Unitron Industries, Inc.1991-11-05
MICRO-AIRE MODEL 2060 (K913369)Micro Surgical Instruments Corp.1991-11-01
ER-1000 CATHERIZATION C-ARM SYSTEMS (K914348)Shimadzu Medical Systems1991-11-01
MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR (K913578)Control-X, Inc.1991-11-01
ENEMA KIT (K913620)York County Blind Center1991-11-01
OIA STREP A (K912889)Biosearch Medical Products, Inc.1991-10-31
CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL (K914469)Cholestech Corp.1991-10-30
GEN-X 800/650 (K914302)Swissray Finatech, Inc.1991-10-30
MICRONAIRE ISO-HOOD MAX 5UV (K912142)Micronaire Corp.1991-10-30
PEEPERS TANNING GOGGLES (K914095)California Suncare, Inc.1991-10-30
MINIFLEX AND PERSONAL UNIT (K912997)Dabi-Atlante America Corp.1991-10-30
PHOSPHOLIPID REAGENT SET (K914040)Sterling Diagnostics, Inc.1991-10-30
ASPIRATION/INJECTION NEEDLE (K913992)Northgate Technologies, Inc.1991-10-30
GEN-X 800/800 (K914301)Swissray Finatech, Inc.1991-10-30
REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 (K913058)Helena Laboratories1991-10-30
AUTOMATED BIOPSY DEVICE, MODIFICATION (K913815)Hart Enterprises, Inc.1991-10-30
DERMASAFE(TH) HYPOALLERGENIC (K914094)Multi-Com Sdn Bhd1991-10-28
SCEPTOR IDENTIFICATION SYSTEM (K912897)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-10-28
ACTION SERIES MANUAL WHEELCHAIRS, VARIOUS MODELS (K914553)Invacare Corp.1991-10-28
MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER (K913590)Dynatech Laboratories, Inc.1991-10-25
POSTERIOR NASAL EPISTAXIS INSTRUMENTS (K911756)Richard Wolf Medical Instruments Corp.1991-10-24
TA620 TREADMILL CONTROLLER (K913518)Siemens Burdick, Inc.1991-10-24
DUET BICYCLE/WHEELCHAIR (K913759)Robert Hoening Mobility Systems, Inc.1991-10-24
MULTI-REACH II WAND MASSAGER (K914344)Conair Corp.1991-10-24
EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR (K911562)Continental X-Ray Corp.1991-10-24
MULTIPLE LATEX PATIENT EXAMINATION GLOVES (K914049)London Rubber Co. (India) , Ltd.1991-10-23
CLEARSITE(R) STERILE WOUND CARE DRESSING (K914207)Ndm Acquisition Corp.1991-10-23
FORTEX(TM) WOUND DRESSING (K914314)Calgon Vestal Div.1991-10-23
MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS (K913964)Marlo Surgical Technology1991-10-23
DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED (K912504)Intertech Resources, Inc.1991-10-23
SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) (K914462)Serono-Baker Diagnostics, Inc.1991-10-23
ANOMALOSCOPE QUADRANT TEST-6 (K913962)Lkc Technologies, Inc.1991-10-23
BODAI NEO2 -SAFE AIRWAY PRESSURE CAP (K913753)B&B Medical Technologies, Inc.1991-10-23
INVENTOR RT/EXPLORER TRAUMA UNIT (K911563)Continental X-Ray Corp.1991-10-23
DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED (K912065)Intertech Resources, Inc.1991-10-23
MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS (K913266)Micro Surgical Instruments Corp.1991-10-21
LIPASE LINEARITY CONTROL (K913585)Creative Laboratory Products, Inc.1991-10-21
DR. DEAN EDELL SOLARBLOC SUNGLASSES (K913640)Cable Car Sunglasses1991-10-21
AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID (K914477)Miracle-Ear, Inc.1991-10-21
PYLORISET (K904655)Orion Diagnostica, Inc.1991-10-21
IMPLARETTE (K911655)Implant Innovations International, Inc.1991-10-21
ACT-II BEHIND THE EAR HEARING AID (K914418)Telex Communications, Inc.1991-10-21
OXYGEN MASKS 81420, 81421, 81471 & 81461 (K913383)Specialty Packaging Producs, Inc.1991-10-18
DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM (K913967)Doxtech, Inc.1991-10-18
MODEL 80 HEARING AID DISPENSING SYSTEM (K913245)3M Company1991-10-18
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