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

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RecordFirmDate
INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING) (K901879)Smith & Nephew United, Inc.1990-06-22
SHIN NIPPON AUTO REFRACTOMETER QR-007N (K901583)Soderberg, Inc.1990-06-22
WEEVAC 6 INFANT EVACUATION STRETCHER (K902521)W. Murphy Ent., Inc.1990-06-22
THE COMPANION NON-ELECTRIC LIFT CHAIR (K902600)Innovative Medical Engineering, Inc.1990-06-21
OSSEOTITE IRRIGATION UNIT (K901600)Collagen Corp.1990-06-21
COLONIC BALLOON DILATOR (K901426)Telemed Systems, Inc.1990-06-21
SPECTACLE FRAME (K900732)Seiko Corp.1990-06-20
MICROMATE 196 MODEL A961960 (K901808)Packard Instrument Co., Inc.1990-06-20
SUNGLASS, NON-PRESCRIPTION (K900764)Seiko Optical Products of America, Inc.1990-06-20
VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE (K902010)Visitec Co.1990-06-20
DRYSLIDE, BETA-LACTAMASE (K901784)Difco Laboratories, Inc.1990-06-20
KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET (K901934)Eastman Kodak Company1990-06-20
SUNGLASSES STYLE #(1137) (K901570)Zaks Stores, Inc.1990-06-20
SUNGLASSES STYLE #(CM-1989) (K901571)Zaks Stores, Inc.1990-06-20
RX ROCKER WHEELCHAIR (K902438)The RX Rocker Corp.1990-06-19
SUNGLASSES STYLE #(70116) (K901572)Zaks Stores, Inc.1990-06-19
RX ROCKER TRIUMPH WHEELCHAIR (K902439)The RX Rocker Corp.1990-06-19
COLORADO COLOR IMAGING RECORDER (K902230)Honeywell, Inc.1990-06-19
MODIFIED DELFIA ESTRADIOL KIT (K902358)Pharmacia, Inc.1990-06-18
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE (K902380)Baxter Healthcare Corp1990-06-18
AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT (K902259)Orthomet, Inc.1990-06-18
WAKO(TM) MICRO-ALBUMIN (K902216)Wako Chemicals USA, Inc.1990-06-18
CIBA CORNING ACS:180 AUTOMATED CHEMILUMINESCENCE (K902336)Ciba Corning Diagnostics Corp.1990-06-18
WATER PIK(R) W/ADD'L CLAIMS (K900547)Teledyne Water Pik1990-06-15
EXPANDACEL NASAL TAMPONS (K900171)Surgitrend, Ltd.1990-06-14
PASSAGE AIRWAY SPLINT (K901307)Invotec International, Inc.1990-06-14
CUSTOM ITE HEARING AID MODEL: H (K902352)Oticon Corp.1990-06-14
(EYEGLASS) FRAMES AND SUNGLASSES (K901167)Optique Marquis, Div. Sugerose, Inc.1990-06-14
CUSTOM ITE HEARING AID MODELS F AND L (K902353)Oticon Corp.1990-06-14
INVOTEC BI-VALVE SPLINT (K901306)Invotec International, Inc.1990-06-14
ULTRASTAT NASAL CATHETER (K901310)Invotec International, Inc.1990-06-14
FRAME, SPECTACLE (K897091)Pt Midas Surya Optical Co.1990-06-14
NUBALOO(R) SUNGLASSES (K901160)Blublocker Corp.1990-06-14
CARAGLAS XTRA SYNTHETIC CASTING TAPE (K896634)Buckman Co., Inc.1990-06-14
CUSTOM ITE HEARING AID MODELS C AND M (K902351)Oticon Corp.1990-06-14
BARTON-MAYO TRACHEOSTOMA BUTTON (K901377)Medical Innovations International, Inc.1990-06-14
LEG EEZE (K901931)Jereva, Inc.1990-06-14
TITAN GLADIATOR ADJUSTING TABLE (K902549)Titan Tables1990-06-13
TITAN APOLLO AND NOVA ADJUSTING TABLES (K902234)Titan Tables1990-06-13
MODULAR FLEXIBLE DRILLING SYSTEM (K901165)Dalton Technology, Inc.1990-06-13
DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER (K901166)Dalton Technology, Inc.1990-06-13
COULTER SERUM IRON/UIBC REAGENT (K902173)Coulter Corp.1990-06-12
BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS (K902095)Phoenix Diagnostics, Inc.1990-06-12
MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST (K901858)E.I. Dupont DE Nemours & Co., Inc.1990-06-12
PROLACTIN (LACTOGEN) TEST SYSTEM (K901673)Baxter Healthcare Corp1990-06-12
TENSOPLUS LITE (K901378)Smith & Nephew United, Inc.1990-06-12
SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM (K896467)Medisense, Inc.1990-06-12
REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO) (K901463)Helena Laboratories1990-06-12
RX ROCKER TRIUMPH, JR. WHEELCHAIR (K902440)The RX Rocker Corp.1990-06-11
CONTINUOUS PASSIVE MOTION (CPM) LEG EXERCISER (K902452)Berner Assoc., Inc.1990-06-11
TITAN ZODIAC ADJUSTING TABLE (K902466)Titan Tables1990-06-11
TITAN HERCULES ADJUSTING TABLE (K902465)Titan Tables1990-06-11
TRANS/R - FP(3) (K900016)CIVCO Medical Instruments Co., Inc.1990-06-11
NIDEK RT-1200S (MARCO TRS-1200) (K901513)Nidek, Inc.1990-06-08
NON-PRESCRIPTION SUNGLASSES (K901036)The Bonneau Co.1990-06-08
MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT (K902366)Synectics-Dantec1990-06-08
ULTRA.SPEC NON-STERILE LATEX EXAMINATION GLOVE (K902282)Ncl Corp.1990-06-07
MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS (K902019)Gynescope Corp.1990-06-07
CHEMOPLUS GLOVE (K901411)Biosafety Systems, Inc.1990-06-07
CROAK OVARIAN BIOPSY FORCEP (K902049)Gynescope Corp.1990-06-07
BEHRING LASER NEPHELOMETER (K761234)Behring Diagnostics, Inc.1990-06-07
PROMISE ABSORBENT PROTECTIVE PAD (K900421)Scott Health Care1990-06-06
ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) (K902266)Phoenix Diagnostics, Inc.1990-06-06
BLOOD GAS CONTROLS (K901985)Phoenix Diagnostics, Inc.1990-06-06
SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM (K896630)Atos Medical AB1990-06-06
PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE (K901796)Component Equipment Mfg., Inc.1990-06-06
RUBBER, DENTAL DAM (NON-STERILE) (K901236)Naturub Sdn. Bhd.1990-06-06
LATEX EXAMINATION GLOVES (K900980)Sinochem (Usa), Inc.1990-06-01
MODIFIED NON-STERILE LATEX EXAMINATION GLOVES (K902181)Aladan Corp.1990-06-01
CP-3 DENTAL POLISHING MATERIAL (K901973)Gresco Products, Inc.1990-06-01
MODIFIED STERILE LATEX EXAMINATION GLOVES (K902182)Aladan Corp.1990-06-01
PATHODX PYR KIT (K902037)Diagnostic Products Corp.1990-06-01
MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE (K900488)American Orthodontics1990-06-01
IRON REAGENTS PRODUCT CODES 7725 AND 7726 (K901960)American Research Products Co.1990-05-31
ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES (K900178)Core-Vent Corp.1990-05-31
DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET (K901988)Casco Standards1990-05-31
BLOOD GAS/CO-OXIMETRY CONTROL (K901976)Phoenix Diagnostics, Inc.1990-05-31
OCULAR INFUSION CANNULA SYSTEM (K901618)Tamcenan Corp.1990-05-31
PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463 (K901964)American Research Products Co.1990-05-31
CO-OXIMETER CONTROLS (K901986)Phoenix Diagnostics, Inc.1990-05-31
A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) (K897195)A Company, Inc.1990-05-31
ROTAG CONTROLS (K900719)Roche Diagnostic Systems, Inc.1990-05-30
MODEL 2000 INTRAOPERATIVE CORNEASCOPE (K901009)Kera Corp.1990-05-30
TABA PATIENT EXAMINATION GLOVES (K901749)R.S.T. Corp.1990-05-30
AUDIOTONE MODEL A-52S BEHIND-THE-EAR HEARING INST. (K901745)Miracle-Ear, Inc.1990-05-29
AUDIOTONE ITE HEARING AID MODEL ZA (MICRO) (K901783)Miracle-Ear, Inc.1990-05-29
AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE) (K901747)Miracle-Ear, Inc.1990-05-29
AUDIOTONE ITE HEARING AID MODEL ZD (XT) (K901746)Miracle-Ear, Inc.1990-05-29
MAYFLOWER BRAND PATIENT EXAMINATION GLOVES (K901376)Kai FU Trading Co.1990-05-29
OCULAR OCCLUDER (K900942)Microdynamics1990-05-25
TOPOGRAPHIC MODELING SYSTEM (K901363)Computed Anatomy, Inc.1990-05-25
KLEIN MICRO-CANNULA(TM) (K901717)Jeff Klein Surgical, Inc.1990-05-24
QUICK CHEM II (K901695)Seradyn, Inc.1990-05-24
IM COLLAGEN SHIELD (K896449)Intermedical, Inc.1990-05-24
KLEIN LAMPREY-CANNULA(TM) (K901718)Jeff Klein Surgical, Inc.1990-05-24
SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE (K901438)Telemed Systems, Inc.1990-05-24
IRRIGATION TRAY (K896800)Westmark, Sterile Packing Systems, Inc. (Sps)1990-05-24
SYLVAN PEDIASCAN 200 TRANSILLUMINATOR (K901309)Sylvan Corp.1990-05-24
DSL C-PEPTIDE RIA (DSL #7000) (K896420)Diagnostic Systems Laboratories, Inc.1990-05-24
BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC (K900829)Phonak, Inc.1990-05-23
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