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

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RecordFirmDate
STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES (K962800)Stryker Instruments1996-09-11
AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY) (K963047)Fenwick Hearing Instruments1996-09-10
DSL DHEA-S-7 (K962895)Diagnostic Systems Laboratories, Inc.1996-09-10
PROSTYLE COMPACT (K961420)Planmeca Oy1996-09-10
PREPOWDER VINYL PATIENT EXAMINATION GLOVES (K962026)Hong Huang Tang Industrial Co., Ltd.1996-09-10
ELECSYS CALCHECK T UPDATE (K963181)Boehringer Mannheim Corp.1996-09-10
AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR) (K961023)Accuimage, Inc.1996-09-09
AIR MAX EXTERNAL NASAL DILATOR STRIP (K962400)American White Cross, Inc.1996-09-09
SUSTAINED PHONATION (K962961)Surface Mount Technology, Inc.1996-09-09
STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3 (K963346)Consolidated Technologies, Inc.1996-09-09
ACUTEK'S CLEARPASAGE (K962698)Acutek Adhesive Specialties, Inc.1996-09-09
DSL ACTIVE FSH IRMA (K962118)Diagnostic Systems Laboratories, Inc.1996-09-09
GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM (K955770)Abaxis, Inc.1996-09-09
AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS (K962798)Hearing Solutions, Inc.1996-09-09
UNITRON MODEL ICON KR (K963122)Unitron Industries, Inc.1996-09-06
DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641 (K962740)Medi-Flex Hospital Products, Inc.1996-09-06
BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER (K961832)Blue Ridge Medical, Inc.1996-09-06
TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND (K962361)Laerdal Medical Corp.1996-09-05
RIONET HB-55S (K963153)Authorized Hearing Systems, Inc.1996-09-05
RIONET HB-54AS (K963154)Authorized Hearing Systems, Inc.1996-09-05
ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER (K962499)Bartels, Inc.1996-09-05
RIONET HB-55AS (K963152)Authorized Hearing Systems, Inc.1996-09-05
OMNI COLD GEL PACKS (K961176)Omni Therm, Inc.1996-09-04
IMNI HOT PACKS (K955788)Omni Therm, Inc.1996-09-04
3D-SPINE (K962377)Skill Technologies, Inc.1996-09-03
LFS LIPOGEL ASSAY KIT (K960785)Zaxis, Inc.1996-09-03
DURASIL (MODIFICATION) (K961410)The S. F. Group, Inc.1996-09-03
DSL 9100 IGF-II IRMA (K962758)Diagnostic Systems Laboratories, Inc.1996-08-30
VARELISA HELICOBACTER PYLORI ANTIBODIES (K953873)Elias U.S.A., Inc.1996-08-30
GRAM NEGATIVE IDENTIFICATION PLUS CARD (K962609)Biomerieux Vitek, Inc.1996-08-30
ELECSYS CALCHECK HCG (K963165)Boehringer Mannheim Corp.1996-08-30
COBAS CORE IMMUNOCHEMISTRY SYSTEM (K962231)Roche Diagnostic Systems, Inc.1996-08-30
FRESHFROZENCELLS (K962311)Diagnostic Hybrids, Inc.1996-08-29
PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM) (K962975)Diagnostic Products Corp.1996-08-29
FRESHFROZEN CELLS, HEP-2 (K962782)Diagnostic Hybrids, Inc.1996-08-29
IMMULITE ACTH CONTROL MODULE (LACCM) (K963240)Diagnostic Products Corp.1996-08-29
FRESHCELLS, HEP-2 (K962780)Diagnostic Hybrids, Inc.1996-08-29
DERMTOME BLADE (K962371)Dsp Worldwide1996-08-29
FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES (K962306)Diagnostic Hybrids, Inc.1996-08-29
MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT (K962228)Ototech Intl., Inc.1996-08-28
ELECSYS CALCHECK FT4 (K963164)Boehringer Mannheim Corp.1996-08-27
CARBOMEDICS HANDLE (K962154)Carbomedics, Inc.1996-08-27
ELECSYS CALCHECK FT3 (K963163)Boehringer Mannheim Corp.1996-08-27
ELECSYS CALCHECK T4 (K963178)Boehringer Mannheim Corp.1996-08-27
IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 (K961587)Diagnostic Chemicals , Ltd.1996-08-27
ELECYS CALCHECK T 3 (K963167)Boehringer Mannheim Corp.1996-08-27
ACRYLIC READING AND POLYCARBONATE LENSES SUNGLASSES (K962279)Jane Fui Optical Co., Ltd.1996-08-26
RAVEN EYE- EYE WEAR (SUNGLASSES) (K963284)Raven Eye, Inc.1996-08-26
RAVEN EYE, INC.- EYE WEAR (K962940)Raven Eye, Inc.1996-08-26
LINEA MILANO SUNGLASSES, KALEIDO SUNGLASSES PLASTIC AND METAL FRAMES (K963083)Piazza Optical Corp.1996-08-26
ELECSYS CALCHECK TROPONIN T (K963143)Boehringer Mannheim Corp.1996-08-23
ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA (K962875)Diagnostic Systems Laboratories, Inc.1996-08-23
MEDLINE PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES (K962094)Medline Industries, Inc.1996-08-23
OPUS HLH (K962866)Behring Diagnostics, Inc.1996-08-23
MEDLINE POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVES,MEDLINE POWDER-FREE STERILE LATEX EXAMINATION GLOVES (K962095)Medline Industries, Inc.1996-08-23
SUNQUEST INTERNATIONAL (K963059)Sunquest Intl., Inc.1996-08-23
ELECSYS CALCHECK CK-MB (K963182)Boehringer Mannheim Corp.1996-08-23
ELECSYS CALCHECK TSH (K963147)Boehringer Mannheim Corp.1996-08-23
MEDLINE PWDER-FREE VIBNYL EXAMIUNATION GLOVES/VINYL GLOVES, STERILE (MDS 192074,5,6) (K962076)Medline Industries, Inc.1996-08-23
NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT (K962982)Nova Biomedical Corp.1996-08-23
FITO DIDO (K963075)Framesmart, Inc.1996-08-22
WEEKS APPLICATOR (K951052)Duke University Medical Center1996-08-22
MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT (K962013)Mentor Corp.1996-08-22
A-DEC SELF-CONTAINED WATER SYSTEM (K962665)A-Dec, Inc.1996-08-22
MARCELLA CARAN (K962912)Framesmart, Inc.1996-08-22
BBL MGIT PRODUCTS (K954932)Becton Dickinson Diagnostic Instrument Systems1996-08-21
IMMAGE IMMUNOCHEMISTRY SYSTEM (K962294)Beckman Instruments, Inc.1996-08-21
UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY (K963116)Diagnostic Chemicals , Ltd.1996-08-20
POWDERFREE BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM (K953958)Codan Medlon, Inc.1996-08-20
BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM (K953956)Codan Medlon, Inc.1996-08-20
POWDERFREE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM (K953955)Codan Medlon, Inc.1996-08-20
LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III (K963085)International Enzymes, Inc.1996-08-20
UROTAC BONE ANCHOR INSERTER (K962372)Influence, Inc.1996-08-19
RADWORKS MEDICAL IMAGING SOFTWARE (K962699)Applicare Medical Imaging, B.V.1996-08-19
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR (K962186)Genzyme Corp.1996-08-19
MEDLINE PRE-POWDERED NON-STERILE/STERILE VINYL EXAMINATION GLOVES (K962069)Medline Industries, Inc.1996-08-19
MICROLAB 4000, MICROLAB 4200 (K961896)Hamilton Co.1996-08-16
ACTIVE ANDROSTENEDIONE EIA (K963002)Diagnostic Systems Laboratories, Inc.1996-08-16
TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60 (K961281)Diagnostic Chemicals , Ltd.1996-08-16
SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR (K962762)Biotraces, Inc.1996-08-16
CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER (K962215)U.S. Medical Products, Inc.1996-08-15
QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET (K961912)Consolidated Technologies, Inc.1996-08-15
OPUS MYOGLOBIN CONTROLS (K962841)Behring Diagnostics, Inc.1996-08-15
PATIENT LATEX EXAMINATION GLOVES (POWDERED, NON STERILE) (K962650)Sti Medical Sdn Bhd1996-08-15
NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3 (K962997)Nova Biomedical Corp.1996-08-15
POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM (K960841)Boston Medical Corp.1996-08-15
ANDELA DYNAMIC COOLING DEVICE (K951033)Candela Laser Corp.1996-08-15
EAGLE EYES SUNGLASSES (K962287)Positive Response Television1996-08-14
NITRILE POWDER-FREE PATIENT EXAMINATION GLOVES (K962461)Shen Wei (Usa), Inc.1996-08-14
MDI TUTOR (K961894)Mdi Tutor, Inc.1996-08-14
SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM (K962789)Smith & Nephew Endoscopy, Inc.1996-08-14
GLOVE, EXAMINATION, VINYL (K952050)Oak Carolina, Inc.1996-08-12
MT10P, MT60-PP, MT60-AGC0, AND MT60 (K962847)Micro-Tech Hearing Instruments1996-08-09
DEPUY DISPOSABLE FILTER/HOOD (K961791)Depuy, Inc.1996-08-09
SINGLE USE INSTRUMENT TRAY (K962328)Medcare Medical Group, Inc.1996-08-09
ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN (K961194)Sil-Med Corp.1996-08-08
BACTEC 9050 SYSTEM (K962210)Becton Dickinson Diagnostic Instrument Systems1996-08-08
DENTAL DAM SILICONE (K961472)Worldwide Dental, Inc.1996-08-07
BONE & MARROW COLLECTION SYSTEM (K961901)Biomedical Ent., Inc.1996-08-06
SPIRIT S1/S2 (K962071)Pelton & Crane Co.1996-08-06
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