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

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RecordFirmDate
LACERATTION TRAY (K920763)Sterile Concepts, Inc.1992-09-28
PRECISE STREP A (K923673)Becton Dickinson Advanced Diagnostics1992-09-28
ORTHODONTIC STAINLESS STEEL BRACKET (K923029)Gac Intl., Inc.1992-09-28
SLIDEX STAPH-KIT (K923212)Biomerieux Vitek, Inc.1992-09-28
AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA (K922457)Microprobe Corp.1992-09-25
WINGMASTER (K921355)Innovators, Inc.1992-09-25
SYVA MICROTRAK CHLAMYDIA EIA (K920503)Syva Co.1992-09-25
MICROTRAK(R) II CHLAMYDIA EIA ASSAY (K921462)Syva Co.1992-09-25
AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS (K923133)Microprobe Corp.1992-09-25
HEMOLAB SILIMAT REAGENT (K920001)Biomerieux Vitek, Inc.1992-09-25
BLUNT TIP IRRIGATION NEEDLES (K921354)Innovators, Inc.1992-09-25
KODAK AMERLITE TOTAL THYROID CONTROL SERA (K923740)Eastman Kodak Company1992-09-25
BTE HEARING AID CLUB MODEL ST70 (K923296)Club Hearing Instruments A/S1992-09-23
NO-SCALPEL VASCETOMY INSTRUMENTS (K922971)Pilling Co.1992-09-23
BTE HEARING AID CLUB MODEL: ST60 (K923294)Club Hearing Instruments A/S1992-09-23
BREAST LESION LOCALIZATION NEEDLE (K924270)Core Medical, Inc.1992-09-23
ITC HEARING AID CLUB MODEL LM40 (K923295)Club Hearing Instruments A/S1992-09-23
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH (K924407)Coloplast A/S1992-09-23
BIO-GUARD LATEX SURGICAL GLOVES (K921664)Network Medical Systems, Inc.1992-09-23
ITC HEARING AID CLUB MODEL LM50H (K923293)Club Hearing Instruments A/S1992-09-23
STERILE LATEX EXAMINATION GLOVES (K922379)Smith & Nephew Perry1992-09-22
MILES AUTO METH DETERMIN OF URIC ACID IN URINE (K924129)Heraeus Kulzer, Inc.1992-09-22
SYSTEMATE URICACID TEST, TECHNICON RA 1000 (K923765)Em Diagnostic Systems, Inc.1992-09-22
MICROBACT SOLID PLATE SYSTEMS (K923342)Radiometer America, Inc.1992-09-22
SYNERMED 600 NM URIC ACID REAGENT KIT (K923414)Synermed, Inc.1992-09-22
SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000 (K923764)Em Diagnostic Systems, Inc.1992-09-22
STRYKER DYNAMIC MATTRESS SYSTEM (DMS) MODEL #2500 (K920526)Stryker Medical1992-09-21
MEDX ROTATIONAL GANTRY SYSTEM (K923356)Bfi- Medical Waste Systems1992-09-21
STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE (K923098)Trinity Laboratories, Inc.1992-09-21
OXYGEN FLOW CONTROLLER (K920783)Puritan Bennett Corp.1992-09-18
HHI ELECTRIC CONSOLE #875-000 (K922056)H&H Instruments1992-09-18
HHI PNEUMATIC ROTARY DRILL (K922661)H&H Instruments1992-09-18
TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL (K922723)Simplicity Diagnostics, Inc.1992-09-18
SEAL RING FOR NASAL CPAP (K921499)Devilbiss Health Care, Inc.1992-09-17
IL TEST ALT, PN 35311 (K923623)Instrumentation Laboratory CO1992-09-17
AMBU OXYGEN REGULATOR (K921125)Amg, LLC1992-09-17
MINIDAM II (K921771)Delsan Dental Systems1992-09-17
OPTICAL FRAMES (K922930)St. Germain Eyewear Intl.1992-09-17
NEOLINE(TM) (K914778)Martech Medical Products, Inc.1992-09-16
ORIGIN SECONDARY CANNULA AND TROCAR (K922460)Origin Medsystems, Inc.1992-09-16
CN ENDOTRACHEAL TUBE HOLDER (K921698)N-C-N Products Co.1992-09-15
STRAPPAL (K922897)Smith & Nephew United, Inc.1992-09-15
SPORICIDIN BRAND DISINFECT TOWELETTES/SPRAY/SOLUT (K922262)Sporicidin Intl.1992-09-15
PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE (K923285)Smith & Nephew, Inc.1992-09-15
IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY (K923060)Becton Dickinson Advanced Diagnostics1992-09-15
J-VAC BULB SUCTION RESERVOIR (K922895)Johnson & Johnson Medical, Inc.1992-09-15
SINGLE DOSE GAS INJECTOR (K923397)Escalon Medical Trek1992-09-14
BENDEREV PROTECT-A-PASS NEEDLE (K921228)Eimark Labs, Inc.1992-09-14
EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA (K921628)Incstar Corp.1992-09-14
SKIN SUPPORT PREP PAD (K923351)Coloplast Corp.1992-09-14
DISPOSABLE FORCEPS (K920296)Falcon Instruments, Inc.1992-09-11
BURN DRESSING (K923846)Medical Action Industries, Inc.1992-09-11
ISOPORE TAPE (K922959)Lectec Corp.1992-09-11
PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED (K923445)Hycor Biomedical, Inc.1992-09-11
SCANMATE III (K921878)Circadian, Inc.1992-09-11
DISPOSABLE SCISSORS (K920297)Falcon Instruments, Inc.1992-09-11
ROCHE ENTEROTUBE II (K922588)Roche Diagnostic Systems, Inc.1992-09-11
DISPSABLE FORCEPS, HEMOSTATS, PROBES, NEEDLE GUIDE (K922874)Supra Instruments, Inc.1992-09-11
TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT (K922814)Bay Shore Medical Equipment Corp.1992-09-11
PNEUMO-WEDGE (K921143)Kansas Creative Devices, Inc.1992-09-11
WATERS(TM) LC MODULE I FOR CLINICAL USE (K922388)Millipore Corp.1992-09-11
FIRST AID KIT (K921976)The Home Emergency Room1992-09-10
CYBERNETIC OPTION (CYBER I) (K923986)Qualitone1992-09-10
IN-THE-EAR HEARING AID (K923918)Benway-Haworth-Lawlor Hearing Aids, Inc.1992-09-10
MRX-865 (K921130)Mrx-Ray Tube Corp.1992-09-10
LUEKOFLEX SURGICAL TAPE (K923404)Beiersdorf, Inc.1992-09-09
SURGISTAR BLADES (K923689)Surgistar, Inc.1992-09-09
CLEANIC (K923020)Hawe Neos Dental1992-09-09
KING DIAGNOSTICS CHOLESTEROL REAGENT (K923128)King Diagnostics, Inc.1992-09-09
ENDOPATH TISSUE RETAINING COMPONENT (K923679)Ethicon Endo-Surgery, Inc.1992-09-09
KING DIAGNOSTICS GAMMA GT REAGENT (K923091)King Diagnostics, Inc.1992-09-09
NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC (K923186)Roho, Inc.1992-09-09
PATIENT EXAMINATION GLOVES (MAYCARE) (K915329)Malaysian Healthcare Sdn. Bhd1992-09-09
OXYGEN SWIVEL ADAPTER (PLASTIC) (K924225)Linjorel Products, Inc.1992-09-04
NEW FREEDOM ULTRA THIN PADS (K920830)Kimberly-Clark Corp.1992-09-04
SUPER GLOVES(R) HYPOALLERGENIC (K922495)Taiping Super Holdings Sdn Bhd1992-09-04
STARKEY LABORATORIES OTOSCOPE (K922752)Starkey Laboratories, Inc.1992-09-04
SPECTACLE FRAMES (K922258)British Optical Import Co.1992-09-02
AMERLITE PROLACTIN-30 ASSAY (K922170)Eastman Kodak Company1992-09-02
BARTELS EPSTEIN-BARR VIRUS IGM EIA (K922331)Baxter Diagnostics, Inc.1992-09-02
LABOTECH AUTOMATED MICROTITER ANALYZER (K922081)Innovative Medical Systems, Inc.1992-09-02
MONI-TROL-L AND MONI-TROL-XL (K920291)Medical Analysis Systems, Inc.1992-09-02
BARTELS EPSTEIN-BARR VIRUS IGG EIA (K922332)Baxter Diagnostics, Inc.1992-09-02
SALIVA-STIM (K914892)Orion Diagnostica, Inc.1992-09-02
BARTELS RUBEOLA IGM EIA (K922335)Baxter Diagnostics, Inc.1992-09-02
THE NISSEL ARTIFICIAL EYE (K923167)Nissel , Ltd.1992-09-02
VISOR SUNGLASSES/LENS/NOVELTY VISOR (K915266)Janlin Ent.1992-09-02
SOLAZ (K921685)Solarchromic, Inc.1992-09-02
BARTELS RUBEOLA IGG EIA (K922330)Baxter Diagnostics, Inc.1992-09-02
MICROGUIDE LESION MARKING SYSTEM (K923120)Angiodynamics, Div. E-Z-Em, Inc.1992-09-01
DEROYAL EYE DRESSING (K923300)Deroyal Industries, Inc.1992-09-01
SHOWERFLOSS (K923457)Summit Marketing Group, Inc.1992-09-01
OPTHALMIC FRAMES (K922687)Optique Forte , Ltd.1992-08-31
CUTINOVA FOAM (K922681)Jobst Institute, Inc.1992-08-31
GLENROE GOLDEN ORTHODONTIC BRACKET (K923124)Glenroe1992-08-27
RUBBER FRAME SUNGLASSES (K922508)Jedda Dist., Inc.1992-08-26
STARKEY SM SERIES BTE HEARING AIDS (K923784)Starkey Laboratories, Inc.1992-08-26
PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT (K923569)Baxter Diagnostics, Inc.1992-08-26
GAC THUMB-SUCKING CONTROL APPLIANCE (K920850)Gac Intl., Inc.1992-08-24
VOICEWAVE (K923924)Personal Sound Technologies, Inc.1992-08-24
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Every clearance here is in the API, with alerts when new ones post.