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

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RecordFirmDate
QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST (K952517)Quidel Corp.1996-02-06
RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE (K955238)Rusch Intl.1996-02-06
DRYSLIDE CARTARRHALIS (K954783)Difco Laboratories, Inc.1996-02-06
IMMULITE TOTAL TESTOSTERONE (K955870)Diagnostic Products Corp.1996-02-06
AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON) (K953968)Aesculap, Inc.1996-02-05
3M NO STING BARRIER FILM (K955103)3M Medical Products Group1996-02-05
ACCESS PROGESTERONE ASSAY (K955769)Bio-Rad Laboratories, Inc.1996-02-05
IL TEST CHOLINESTERASE (K943367)Instrumentation Laboratory CO1996-02-05
LYPHOCHEK BENZO/TCA CONTROL-SET B (K955153)Bio-Rad1996-02-05
HEARING AID IMPRESSION MATERIAL (K955288)Crown Delta Corp.1996-02-02
RESOUND PERSONAL HEARING SYSTEM BT247 (K955867)Resound Corp.1996-02-02
NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION (K955260)Nova Biomedical Corp.1996-02-02
OPTUS OTOSCOPES (K945264)Optus, Inc.1996-02-02
NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2 (K955264)Nova Biomedical Corp.1996-02-02
HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES (K954294)Thermotrex Corp.1996-02-02
JPI INTENSIFYING SCREEN (K954161)Jpi Healthcare Co, Ltd.1996-02-02
NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4 (K955252)Nova Biomedical Corp.1996-02-02
FINETONE FSC, (K955692)Finetone Hearing Instruments1996-02-02
NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT (K950481)Isolab, Inc.1996-02-01
RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY (K955683)Contour Fabricators of Florida, Inc.1996-02-01
OLYMPUS URIC ACID REAGENT (K955752)Olympus America, Inc.1996-01-31
ILLUMINATOR (K954787)Hospitak, Inc.1996-01-31
OLYMPIC SMART SCALE MODEL 50/50RA (K955357)Olympic Medical Corp.1996-01-30
TREBAY MICRODEBRIDER SYSTEM (K955704)Trebay Medical Corp.1996-01-30
DRYSIDE NEISSERIA (K954784)Difco Laboratories, Inc.1996-01-30
HM-CAP CONTROL PANEL (K954926)E-Z-Em, Inc.1996-01-30
STRYKER SAGITTAL SAW ATTACHMENT (K954483)Stryker Instruments1996-01-30
SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION) (K955482)Advantage Medical Services, Inc.1996-01-30
HEAT & MOISTURE EXCHANGER (K955008)Intertech Resources, Inc.1996-01-30
TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR (K955018)Instrumentarium Corp.1996-01-30
MANUAL MASSAGE ROLLER (K936312)Mckenna & Cuneo1996-01-29
PLASTIC FRAME, METAL FRAME, OPTICAL (K955695)Dah Sing Trading Co.1996-01-29
ZONG RONG SUNGLASSES (K955441)Zong Rong Glasses Ltd. Co.1996-01-29
LILY DARK VIEWER (K954998)Lily Imaging Solutions Co.1996-01-29
MTC 7707 HIGH SPEED AIR TURBINE (K945256)Mtc Industries and Research, Ltd.1996-01-29
ZONG RONG SUNGLASSES (K955287)Yuu Yeng Enterprise Co., Ltd.1996-01-29
AMPRI (K954002)Ampri Rubberware Industries Sdn Bhd1996-01-29
URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) (K955438)Teco Diagnostics1996-01-29
PROTEC COTTON PADDING BANDAGE (K955320)Derivadas Degasa S.A. DE C.V.1996-01-26
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) (K952819)Abbott Laboratories1996-01-26
DENTAL DAM (K954990)The Hygenic Corp.1996-01-26
DURALASTIC SILICONE TUBING (K955433)Allied Biomedical Corp.1996-01-26
ARISTA VINYL EXAMINATION GLOVES (K954153)Arista Latindo Industrial Ltd. P.T1996-01-26
E-Z FLEX (K953456)Fluid Motion Biotechnologies, Inc.1996-01-26
REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE (K955000)Cerner Corp.1996-01-26
BLOOD GAS MIXTURES (K954803)Mittler Supply, Inc.1996-01-25
LUNG DIFFUSION MIXTURES (K954804)Mittler Supply, Inc.1996-01-25
LYELL SOUND (K954972)Venture Management Corp.1996-01-24
U-TEX (K955810)Laborie Medical Technologies, Ltd.1996-01-24
ACCULUPE (K955184)E For M Imaging Systems Div., Marquette Electronic1996-01-24
CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05 (K955498)Diagnostic Chemicals , Ltd.1996-01-24
MIRACLE EAR MIRAGE (K954119)Miracle-Ear, Inc.1996-01-24
OLYMPUS FB SERIES BIOPSY FORCEPS (K955065)Olympus America, Inc.1996-01-24
HEMO-BARRIER (K953500)Asia Dynamics, Inc.1996-01-24
NIOMED SURGICAL HOOD (K954454)Amerasia Corp.1996-01-23
KLORMAN (K923693)Matrix Medica, Inc.1996-01-23
POWDER-FREE LATES EXAM GLOVES WITH PROTEIN CLAIM (K955029)Shen Wei (Usa), Inc.1996-01-23
GRIP-A-BOOTS (K955463)Sil-Med Corp.1996-01-23
NIOMED BOUFFANT CAPS (K954455)Amerasia Corp.1996-01-23
NULIFE (K955055)Med-Tech Rubber & Engineering Industries1996-01-23
ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM (K952495)Orthopedic Systems, Inc.1996-01-22
SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY (K955174)Sodem Diffusion SA1996-01-22
3M MINI-DRIVER ELECTRIC SYSTEM (K955098)3M Company1996-01-22
WRIGHT MEDICAL TECHNOLOGY SAWBLADES (K955229)Wrightmedicaltechnologyinc1996-01-18
MICROAIRE SMARTDRIVE SYSTEM (K955591)Microaire Surgical Instruments, Inc.1996-01-18
ASPACH 65,000 (MODIFICATION) (K955084)The Anspach Effort, Inc.1996-01-17
REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS (K954922)Rexton, Inc.1996-01-17
ADHESIVE BANDAGES WITH OTC DRUG (K943314)Johnson & Johnson Consumer Products, Inc.1996-01-17
MICRO-DISPENSER 7000 & MICRODISPENSER 8000 (K954722)NOUVAG AG1996-01-16
PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS (K954790)Tulsa Dental Products, Ltd.1996-01-16
SUNGLASSES WITH IMPACT RESISTANT LENSES (K955572)Diamond Mark International Co., Ltd.1996-01-11
IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION (K940564)Dako Diagnostics , Ltd.1996-01-11
DEROYAL INDUSTRIES INFANT HEEL WARMER (K954716)Debusk Knitting Mills, Div. Deroyal Industries1996-01-11
MOONSHADES SUNGLASSES (K954659)Blublocker Corp.1996-01-11
SURGEON'S CAP (K953879)American Threshold Industries, Inc.1996-01-05
COMPU-BLEND EPILATOR (K954031)R. A. Fischer Co. Corp.1996-01-05
EXPRESSAIRE TORUNIQUET SYSTEM (K955552)Smith & Nephew Richards, Inc.1996-01-05
PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM (K953077)Beckman Instruments, Inc.1996-01-05
BOUFFANT CAP (K953878)American Threshold Industries, Inc.1996-01-05
MEDIASTINAL SILICONE DRAINS (K942709)Sil-Med Corp.1996-01-04
MEDTROL DENTAL KIT (K953707)Medtrol, Inc.1996-01-04
PATIENT EXAMINATION GLOVES (K953462)P.T. Irama Dinamika Latex1996-01-04
PHASE CHANGE DENTAL LUBRICANT (K954991)Phase Change1996-01-04
UNISUN (K955539)Steven Chen1996-01-03
KMANZ II (K955611)Gatorz LLC1996-01-03
PYRILINKS-D ASSAY KIT (K952320)Metra Biosystems, Inc.1995-12-29
CONDENSATE COLLECTION KIT (K954480)Nova-Ventrx1995-12-29
BTE CPM-20 (K955106)Baltimore Therapeutic Equipment Co.1995-12-29
INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY (K955390)Corning Nichols Diagnostics1995-12-29
CONVEEN URINE BAG - STERILE (K955609)Coloplast Corp.1995-12-29
BTE CPM-10 (K955105)Baltimore Therapeutic Equipment Co.1995-12-29
SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE (K954438)Rms Div.1995-12-29
AUGUSTINE INTUBATION GUIDE (K954446)Augustine Medical, Inc.1995-12-29
SURGEONS GLOVE POWDER FREE (K953358)American Pro Latex, Inc.1995-12-28
RANIR HI-TECHNOLOGY DENTAL FLOSS (K955530)Ranir/Dcp Corp.1995-12-28
FLEXIBLE INTRAMEDULLARY REAMER (K954915)Zimmer, Inc.1995-12-28
J SINGLE USE HEAD AND JD REUSABLE HANDLE (K950555)Micro-Mega Societe Anonyme1995-12-28
ULTRAFIT LINERS (K954314)Stahmer Weston Scientific1995-12-28
POWDER FREE PLUS PATIENT EXAMINATION GLOVE (K954855)Tillotson Healthcare Corp.1995-12-28
MEPORE PLUS (9X15CM) (K954275)Scott Health Care1995-12-27
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Every clearance here is in the API, with alerts when new ones post.