Atlas FDA

1

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

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
AUTO MASH (K854604)Dynatech Corp.1985-12-06
ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST (K853738)Ortho Diagnostic Systems, Inc.1985-12-06
DEDO SUCTION CANNULA (K854005)Dedo Manufacturer, Inc.1985-12-06
MULTI MASH 2000 (K854603)Dynatech Corp.1985-12-06
PENICILLIN/STREPTOMYCIN SOLUTION (K854567)Mediatech, Inc.1985-12-06
MINI MASH 2000 (K854602)Dynatech Corp.1985-12-06
AMIZYME-EBV TEST KIT (K842530)Amico Lab, Inc.1985-12-06
TERUMO SENSIBEAD EIA COLORIMETER (K854210)Terumo Medical Corp.1985-12-05
REPLACEMENT PUMP TUBING (K853621)Shaban Mfg. Co.1985-12-05
ABBOTT STREP A P.S.D. (K852266)Abbott Laboratories1985-12-05
PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE (K854057)Beckman Instruments, Inc.1985-12-05
RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR (K853848)Medical Graphics Corp.1985-12-05
RESPIRATORY SYNCYTIAL VIRUS ID REAGENT (K853695)Viromed Laboratories, Inc.1985-12-04
PY-RITE (K853758)Golden Dental Products, Inc.1985-12-03
SERIES 2000 MEDS MASK (K853785)Med Systems1985-12-03
HEADSTRAP (K854537)Life Design Systems, Inc.1985-12-03
AMERICAN PHARMASEAL HUMIDAIR CONDENSER (K854012)American Pharmaseal Div. Ahsc1985-12-03
FOUR CHANNEL PH PROBE (K853280)Akron City Hospital1985-12-02
TUBING CLAMP CAT#1000-A (K854512)Rao Medical Devices, Inc.1985-12-02
BLADE, SCALPEL (K854561)Medelec Intl. Corp.1985-12-02
NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET (K854517)Travenol Laboratories, S.A.1985-12-02
WIDEX MODEL M1 (K853793)Widex Hearing Aid Co., Inc.1985-12-02
FLOSPIK (K853767)Medelco , Ltd.1985-12-02
V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP (K854568)American V. Mueller1985-12-02
VOYAGEUR, BUTTERFLY ONE, CADET LAURENTIAN, HORIZON (K854497)Canadian Wheelchair1985-12-02
DEPEND FITTED BRIEF (K854378)Kimberly-Clark Corp.1985-12-02
EDEC 2000 (K852908)Electromed Intl., Ltd.1985-11-29
AUTOSCAN W/A SYSTEM (K854448)American Micro Scan1985-11-26
PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS (K853554)Kallestad Laboratories, Inc.1985-11-26
UNITEK LIFT-OFF DEBRACKETING INSTRUMENT (K854088)Unitex Corp.1985-11-26
RAICHEM/K.E (K854540)Reagents Applications, Inc.1985-11-26
TECHNICON RA-500 SYSTEM (K854345)Technicon Instruments Corp.1985-11-26
ALT(OPTIMIZED) REAGENT (K854502)Sigma Diagnostics, Inc.1985-11-25
IN-VITRO TEST DETERMINATION OF URIC ACID (K854185)Clinical Data, Inc.1985-11-25
PLASTELAST AND/OR ELASTOPLASTE (K854006)Cp Medical1985-11-25
IN-VITRO TEST DETERMINATION OF TRIALYCERIDE (K854182)Clinical Data, Inc.1985-11-25
IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL (K854179)Clinical Data, Inc.1985-11-25
CANTROL SPINAL FLUID CONTROL (K854190)Canyon Diagnostics, Inc.1985-11-25
IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO (K854188)Clinical Data, Inc.1985-11-25
ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD (K854366)American Monitor Corp.1985-11-25
DELTA-LITE CASTING RESIN (K854341)Johnson & Johnson Professionals, Inc.1985-11-22
MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL (K854420)Meadox Surgimed, Inc.1985-11-22
THE NEW MCINTYRE CANNULA (K853777)Microsurgical Technology, Inc.1985-11-21
BARD PARKER 150CC BELLOWS RESERVOIR (K854424)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-20
IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES (K854423)Dynatech Laboratories, Inc.1985-11-20
WIRE CUTTING PLIERS OR LINEMAN'S PLIERS (K854390)Med-Tool, Inc.1985-11-19
MR 700 MICROPLATE READER 012-700-1000 (K854303)Dynatech Laboratories, Inc.1985-11-19
ROUND SUCTION DRAIN (K854418)Sil-Med Corp.1985-11-19
JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2 (K853470)Toshiba Medical Systems1985-11-19
I.C.L.S. COMPULYZER (K854055)Integrated Computerized Laboratory Systems, Inc.1985-11-19
ES 22 (K854243)Boehringer Mannheim Corp.1985-11-19
ADULT ABSORBENT INCONTINENT BRIEF (K854408)Weyerhaeuser Co.1985-11-19
SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000 (K851625)Eaton Medical Group1985-11-19
CDC ANAEROBE BLOOD AGAR (K854455)R. Kent Richards, Inc.1985-11-18
COLUMBIA CNA AGAR W/5% SHEEP BLOOD (K854457)R. Kent Richards, Inc.1985-11-18
TRYPTIC SOY BLOOD AGAR (K854454)R. Kent Richards, Inc.1985-11-18
P.E.Z. AGAR (PHENYLETHANOL AGAR) (K854453)R. Kent Richards, Inc.1985-11-18
HEKTOEN ENTERIC AGAR (K854449)R. Kent Richards, Inc.1985-11-18
SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO (K853648)Synectics-Dantec1985-11-18
CAMPYLOBACTER BLOOD AGAR (K854456)R. Kent Richards, Inc.1985-11-18
MANNITOL SALT AGAR (K854452)R. Kent Richards, Inc.1985-11-18
BILE ESCULIN AZIDE AGAR (K854450)R. Kent Richards, Inc.1985-11-18
SUPER SLICK (K853882)Tang Products1985-11-18
COMBO 36 (K854257)Kg Engineering, Inc.1985-11-18
TENSION-ISOMETER (K854254)Medmetric Corp.1985-11-15
OXYCOIL (K854239)Chad Therapeutics, Inc.1985-11-14
MORGAN SUTURE-DRILL (K853376)Bowen & Company, Inc.1985-11-13
CAMBRIDGE MODEL XT1000 (K854283)Cambridge Medical Instruments, Inc.1985-11-13
ANADIAS NASAL SAW BLADES (K854192)Anadias, Inc.1985-11-13
SUBCUTANEOUS TUNNELING NEEDLES & HANDLES (K854327)Concord Laboratories, Inc.1985-11-13
SANA-LUBE (K853653)Huntington Laboratories, Inc.1985-11-13
THE DEXTRA PRECISION POWER UNIT (K853778)Storz Instrument Co.1985-11-13
NEEDLE W/STYLET FOR IMPLANTATION (K854238)Microvasive1985-11-13
SURGICAL & DENTAL INSTRUMENT (K854146)Baort, Inc.1985-11-13
DOUBLE ANTIBODY C-PEPTIDE RIA KIT (K854066)Diagnostic Products Corp.1985-11-12
KODAKEKTACHEM DTR MODULE (K854138)Eastman Kodak Company1985-11-12
SIOM (K854343)South West Intl., Inc.1985-11-12
LEUCO PREP (K854093)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-12
THE ULTRA-MATE LENS (K854218)Optical Systems Intl., Inc.1985-11-12
DART IRON & IRON BINDING CAPACITY REAGENT (K854305)Coulter Electronics, Inc.1985-11-12
KERATOLUX (K854383)Carl Zeiss, Inc.1985-11-12
MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT (K852932)Microbix Biosystems, Inc.1985-11-12
VIROGEN ROTATEST SLIDE TEST (K853399)Armkel, LLC1985-11-12
TECHNA VISION AUTO-PERIMETER (K853290)Techna Vision1985-11-12
SUNGLASSES/OPTICAL FRAMES (K854264)Wha Chun Industries, Co., Ltd.1985-11-12
OE SERIES OF BEHIND-THE-EAR HEARING AIDS (K853381)Emtech Laboratories1985-11-08
ALPHA CHUCK (K853970)Rocky Mountain Medical Corp.1985-11-08
ECHO TYPE 16 CF ANTIGEN (K853156)Hillcrest Biologicals1985-11-07
THE VICKERS STANDARD MICROSURGERY SET (K853161)Keeler Instruments, Inc.1985-11-07
MEDIPART CORRUGATED POLYETHYLENE & E.V.A. TUBING (K853569)Medipart Jerry Alexander1985-11-07
ECHO TYPE 30 CF ANTIGEN (K853165)Hillcrest Biologicals1985-11-07
COXSACKIE A2 CF ANTIGEN, A4, A10 & A16 (K853279)Hillcrest Biologicals1985-11-07
VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND (K853179)Keeler Instruments, Inc.1985-11-07
POLIO TYPE I CF ANTIGEN, & TYPE II, III (K853278)Hillcrest Biologicals1985-11-07
UNITRON MODEL UM60-PP (K853781)Unitron Industries, Inc.1985-11-07
RESIN TRAY IMPRESSION MATERIAL (K854042)Dentsply Intl.1985-11-07
ECHO TYPE 11 CF ANTIGEN (K853157)Hillcrest Biologicals1985-11-07
HEARING AID(ALL IN EAR) (K852244)Olympia Instruments, Inc.1985-11-07
UNITRON MODEL UM60-D (K853780)Unitron Industries, Inc.1985-11-07
BELIEVE HEAVY FLOW PROTECTION LABIAL PADS (K853630)Kimberly-Clark Corp.1985-11-07
← Previous Next →

Track 1 automatically

Every clearance here is in the API, with alerts when new ones post.