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

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RecordFirmDate
FLOSSBRUSH WITH FLUORIDE (K964976)Flossbrush Interdental Cleaner and Applicator1997-05-06
SAFESKIN POWDERED EXAMINATION GLOVE (K970899)Safeskin Corp.1997-05-06
CUSTOM OPTICAL SUNGLASS FRAMES (K970895)Custom Optical Frames, Inc.1997-05-06
BARAKKA, INFERNO, STERLING, AND/OR ONE (K970944)Sentinal Importing Corp.1997-05-06
SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) (K971466)Carolina Liquid Chemistries Corp.1997-05-06
SANI-SHIELD (K970104)Dw Industries, Inc.1997-05-06
HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION) (K970476)Hwa Mao Optical Co., Ltd.1997-05-06
EVEREST SUNGLASSES (K970315)Ycc International Corp.1997-05-06
ANSPACH LUBRICATING SYSTEM II (K970530)The Anspach Effort, Inc.1997-05-05
VIDAS ROTAVIRUS ASSAY (K965092)Biomerieux Vitek, Inc.1997-05-05
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) (K963054)Genbio1997-05-05
APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE (K971498)Applied Medical Resources1997-05-05
DIGIT-GRIP WITH LCD (DGR002) (K970870)Nk Biotechnical Corp.1997-05-02
PRECISE IMPRESSION KIT (K970952)Starkey Laboratories, Inc.1997-05-02
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 (K963055)Genbio1997-05-02
MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE (K970652)Mitra Imaging, Inc.1997-05-02
RIS SCANVIEW SYSTEM (RSVS) (K970641)Radiology Information Systems, Inc.1997-05-02
FREEPIX/PIXPACS DICOM/HTTP GATEWAY (K970174)Pixelinks, Inc.1997-05-01
STRYKER 2115 REPLACEMENT BATTERY (2115) (K970378)Implant Resource, Inc.1997-04-30
ALIGNMENT INSTRUMENT (K970345)Richard Wolf Medical Instruments Corp.1997-04-29
ADVENTURER (K971142)T.E.S., Ltd.1997-04-28
VSA 3000 VIBRATORYN SENSORY ANALYZER (K970180)Eare Consulting Service1997-04-25
PYR SWAB (K970832)Remel, Inc.1997-04-24
UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) (K970519)Unitron Industries, Inc.1997-04-24
LIQUID LIGAND 1,2,3 (K971071)Chiron Diagnostics Corp.1997-04-23
LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS (K971014)Lifescan, Inc.1997-04-23
MONARCH IOL DELIVERY SYSTEM (K970033)Alcon Laboratories1997-04-23
BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE (K970930)Cleft Palate Appliances, Inc.1997-04-23
SERVOTRONIC EC100 SYSTEM (K962087)Medicon, Inc.1997-04-23
E-Z SPACER MASK (SMALL) (K964956)Airpharma, LLC1997-04-23
NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE (K965095)Ansell Edmont Industrial, Inc.1997-04-22
EUDERMIC HYPOALLERGENIC SURGICAL GLOVES/EUDERMIC SURGICAL GLOVES (VARIOUS) (K964440)Maxxim Medical1997-04-22
VINYL EXAM GLOVE POWERED (K970144)Hiyi Export Co.1997-04-22
COMFORT CATH CHOICE MALE EXTERNAL CATHETER (K970966)Sierra Laboratories, Inc.1997-04-22
SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS (K970314)Beckman Instruments, Inc.1997-04-21
MINI SAMPLER PROCESSOR (K970616)Cavro Scientific Instruments, Inc.1997-04-21
URIC ACID REAGENT (K970867)Derma Media Lab., Inc.1997-04-21
ALT OR SGPT (K971323)Carolina Liquid Chemistries Corp.1997-04-21
SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT (K971363)Carolina Liquid Chemistries Corp.1997-04-21
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT (K965033)Beckman Instruments, Inc.1997-04-21
TRIGLYCERIDES (K971005)Derma Media Lab., Inc.1997-04-21
IN THE EAR HEARING AID (K964898)Keytone Hearing Laboratory1997-04-21
POWERED TOOTHBRUSH (K970381)Emjoi Action USA, Ltd.1997-04-18
LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 (K970778)More Diagnostics1997-04-17
SASI-DC1TS (K970580)Substance Abuse Specialties, Inc.1997-04-17
SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS (K971210)Beckman Instruments, Inc.1997-04-17
IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT (K965035)Beckman Instruments, Inc.1997-04-17
GRAM SWAB (K970834)Remel, Inc.1997-04-17
PROXIDERM (D-460,D 90 460,D 180,460, PS 460) (K970439)Progressive Surgical Products, Inc.1997-04-16
URIC, UA, OR URIC ACID (K971133)Carolina Liquid Chemistries Corp.1997-04-14
PATIENT RESTRAINTS (K970274)Fla Orthopedics, Inc.1997-04-11
PATIENT RESTRAINTS (K970273)Fla Orthopedics, Inc.1997-04-11
PATIENT RESTRAINTS (K970275)Fla Orthopedics, Inc.1997-04-11
PATIENT RESTRAINT (K970272)Fla Orthopedics, Inc.1997-04-11
IMMULITE THYROID AUTOANTIBODY CONTROL MODULE (K971051)Diagnostic Products Corp.1997-04-10
OTOSILK OTOLOGICAL GRAFT DRESSING (K964534)Boston Medical Products, Inc.1997-04-09
CARDIOISOZYME, CK/LD ISOENZYME CONTROL (K970856)Medical Analysis Systems, Inc.1997-04-08
CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5 (K970956)Chiron Diagnostics Corp.1997-04-08
SPINALSCOPICS (K970862)Quantimetrix Corp.1997-04-08
VIDAS C. DIFFICILE TOXIN A II ASSAY (K964887)Biomerieux Vitek, Inc.1997-04-08
IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER (K970227)Dpc Cirrus1997-04-08
ORGENTEC MICRO-ALBUMIN EIA ASSAY (K970932)American Laboratory Products Co., Ltd.1997-04-08
DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404) (K971058)Medical Analysis Systems, Inc.1997-04-08
RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1: (K970088)Richard Wolf Medical Instruments Corp.1997-04-07
KODAK EKTASIAN HG FILM (EHG-15) (K970154)Eastman Kodak Company1997-04-04
EASY CAM (K970626)I.C.S.1997-04-04
KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) (K970399)Allegiance Healthcare Corp.1997-04-03
THE ELECSYS CALCHECK PROGESTERONE (K970984)Boehringer Mannheim Corp.1997-04-02
INDOLE SWAB (K970833)Remel, Inc.1997-04-02
DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) (K970701)Diagnostic Systems Laboratories, Inc.1997-04-02
CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 (K970976)Medical Analysis Systems, Inc.1997-04-02
ESG-1 ELECTROSONOGRAM (ESG-1) (K970116)Myo-Tronics, Inc.1997-04-02
LIQUID CSF(LCR)1, LIQUID CSF(LCR)2 (K970979)Chiron Diagnostics Corp.1997-04-02
MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE (K970308)Mentor Urology, Inc.1997-04-02
REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE (K970924)Regent Medical1997-04-01
PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES) (K970377)Plancon Instruments1997-03-31
MULTI-CHANNEL COMPRESSION BTE (SD) (K970262)Miracle-Ear, Inc.1997-03-31
ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT (K963843)Micro Motors, Inc.1997-03-31
PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE (K962370)Challenge Products, Inc.1997-03-31
AUDALLION II HEARING SYSTEM (K970215)Resound Corp.1997-03-31
ACRYPAK FOLDER (K965185)Alcon Laboratories1997-03-31
STYLE EYES OPTICS (K970744)Anti-Ray, Inc.1997-03-31
ACCESSPOINT, MED E-MAIL, DICOM READER (K963936)Biosound, Inc.1997-03-31
CUFFED OROPHARYNGEAL AIRWAY (COPA) (K955721)Mallinckrodt Medical1997-03-28
REXTON MODEL 48 AND 49PP (K970537)Rexton, Inc.1997-03-28
AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX (K963293)Augustine Medical, Inc.1997-03-28
UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) (K970046)Accutron, Inc.1997-03-28
PARAMAX TRIGLYCERID REAGENT (K964346)Dade Intl., Inc.1997-03-28
FAST TRACT TRANSTRACHEAL PROCEDURE KIT (K970018)L.W. Ward and Assoc., Inc.1997-03-28
GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM (K962687)Nichols Institute Diagnostics1997-03-28
CONVERTORS IMPERVIOUS SHOE COVERS (K970815)Allegiance Healthcare Corp.1997-03-27
JIAWANG POWDER-FREE VINYL EXAMINATION GLOVES (K970111)Shanghai Jiawang Industrial Co. , Ltd.1997-03-27
POLY-MED (K970625)Shinemound Enterprise, Inc.1997-03-27
WIDEX SENSO DIGITAL (CIC) (K970904)Widex Hearing Aid Co., Inc.1997-03-26
MAGNESIUM (K964915)Derma Media Lab., Inc.1997-03-26
MAGNO ALARM (K960849)Cardiac Assist Devices, Inc.1997-03-26
ORBSHOT KERATOMETER (K964891)Orbtek, Inc.1997-03-26
VICTORY EYEWEAR CO (K970538)Victory Eyewear Co., Ltd.1997-03-25
HEDGES CORNEAL WETTING PAK (K970161)Hedges Cwp, Inc.1997-03-25
CORE AND COIL ASSEMBLY GUIDEWIRE (K970994)Lake Region Mfg., Inc.1997-03-25
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Every clearance here is in the API, with alerts when new ones post.