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
VENETO COLLECTION (K912034)Atlantic Optical Co., Inc.1991-08-22
GAP-IGG (K900343)Biomerica, Inc.1991-08-22
BACTI-SWAB(TM) NPG (K912832)Remel Co.1991-08-22
INTRAORAL DENTAL WAX (K910676)Pemaco, Inc.1991-08-21
MATRX, PYRAMID TRIANGLE BANDAGE (K912661)Matrix Medica, Inc.1991-08-21
STAR*SHADES(TM) SUNGLASSES (K912608)Nalpac , Ltd.1991-08-21
POLYESTER RESIN HAND MOLDED TRAY (K912820)E&D Dental Products, Inc.1991-08-21
HEART CATH TRAY (K912052)Medical Device Inspection Co., Inc.1991-08-20
SKIN SAVER(TM) TUBING HOLDER, MODEL 467 (K912197)Alpine Specialties, Inc.1991-08-20
ENDO-CORE (K912720)Metalor Dental USA Corp.1991-08-20
NOZOVENT, NASAL DILATOR (K904290)Wpm Intl AB Intl Trade & Managemet Consulting1991-08-20
I.V. SKY-HOOK (K912010)Dina - Industria, Comercio E Exportacao , Ltd.1991-08-19
22MM ID/OD ADAPTER (K911263)Monaghan Medical Corp.1991-08-19
JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION (K912537)Thera Kinetics, Inc.1991-08-16
ENZYMATICS, INC., TOTAL CHOLESTEROL TEST (K911692)Enzymatics C/O Burditt,Bowles,Radzius & Ruberry1991-08-16
HIGH DENSITY LIPOPROTEIN CHOLESTEROL (K912823)Creative Laboratory Products, Inc.1991-08-16
JACE MODEL T300 TOE CPM DEVICE (K913227)Thera Kinetics, Inc.1991-08-16
OPUS(R) PROLACTIN TEST SYSTEM (K913280)Pb Diagnostic Systems, Inc.1991-08-16
PLANUSTAR AND DENS NOBILIS DENTURE TEETH (K912989)Wilde-USA, Inc.1991-08-16
EXPANDACEL NASAL TAMPONS, MODIFICATION (K912524)Surgitrend, Ltd.1991-08-15
UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION (K911328)Intertech Resources, Inc.1991-08-15
DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED (K912550)Convatec, A Division of E.R. Squibb & Sons1991-08-14
PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE (K912171)Jack James1991-08-13
DASH IV (K912929)Astro-Med, Inc.1991-08-13
FIBER OPTIC UNIVERAL CABLES, SCOPE ADAP., LT.SOURC (K912767)Microaire Advanced Surgical Products1991-08-13
DENTA SAFE(TM) LATEX EXAMINATION GLOVES (K912999)Dental Care Intl., Inc.1991-08-13
DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL (K912455)Baxter Healthcare Corp1991-08-12
SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 (K912827)Cala Diagnostics1991-08-12
URESIL GENERAL PURPOSE DRAINAGE CATHETER (K912109)Uresil Corp.1991-08-12
CHOLINESTERASE TEST KIT (K912148)Crestat Diagnostics, Inc.1991-08-12
FSH IRMA IMMUNOMAG (K912804)Pantex, Div. Bio-Analysis, Inc.1991-08-12
ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ (K913107)Roche Diagnostic Systems, Inc.1991-08-12
BIOTROL UIBC REAGENT (K912795)Biotrol, USA, Inc.1991-08-12
ROCHE REAGENT FOR AMMONIA (K913124)Roche Diagnostic Systems, Inc.1991-08-12
STASIS BUTTON PRSSURE DEVICE (K912765)Arch Development Group1991-08-12
SHBG (K912850)Wien Laboratories, Inc.1991-08-12
ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14 (K912809)Em Diagnostic Systems, Inc.1991-08-12
XYZ CRANK IMAGING TABLE (K911691)Med-Tron Products, Inc.1991-08-09
TBD KERATOSCOPE (K912130)Alcon Laboratories1991-08-09
MOTOR MASSAGE PILLOW (K912479)Supreme Import , Ltd.1991-08-09
MAJOR BASIN TRAY (K912104)Medical Device Inspection Co., Inc.1991-08-09
INTRAVASCULAR CATHETER SECURMENT DEVICE (K912211)Inman Liebelt Corp.1991-08-09
FMA TRANSLATOR (K912086)Normandie Group, Inc.1991-08-07
LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING (K912269)Ocular Instruments, Inc.1991-08-07
TUBE HOUSING ASSEMBLIES (K912338)Comet Ltd. C/O Radiology Resources, Inc.1991-08-07
LATEX EXAMINATION GLOVES (K913033)Reagent Hospital Prod. , Ltd.1991-08-07
GROUP A STREP POSITIVE AND NEGATIVE CONTROLS (K912868)Quidel Corp.1991-08-07
LANDERS NOTCHED VITRECTOMY LENS RING (K912268)Ocular Instruments, Inc.1991-08-07
GUARANTY HAIR REMOVAL SYSTEM (K905125)Stephens Mfg. Co.1991-08-05
TECNADYNE SURGI-SQUEEZE INFUSION PUMP (K910926)Tecnadyne Scientific, Inc.1991-08-02
ECT CARBON FIBER PALLET, MODIFICATION (K912481)Siemens Gammasonics, Inc.1991-08-02
LATEX EXAMINATION GLOVES (K912988)La Glove (M) Sdn. Bhd.1991-08-02
CARDIAC SPECT PALLET (K912286)Siemens Gammasonics, Inc.1991-08-02
CALIBRATION KIT (K911264)S & W Medico Teknik1991-08-02
FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES (K912022)Fraass Survival Systems, Inc.1991-08-02
HEARING AID, UNITRON MODEL UIK (K912870)Unitron Industries, Inc.1991-07-31
E.T. TAPE II (K912884)B&B Medical Technologies, Inc.1991-07-31
RHYTHM (K912938)Stellate Systems1991-07-30
SYNERMED SERUM IRON-600 REAGENT KIT (K912912)Synermed, Inc.1991-07-30
CYTOCLONE A & B EIA (K911958)Cambridge Biotech Corp.1991-07-30
STRYKER ECLIPSE WARMING STRETCHER (K912237)Stryker Medical1991-07-30
MECONIUM ASPIRATION (K912596)Pacific Device, Inc.1991-07-30
MEDIKEEPER (K912346)Medikeeper, Inc.1991-07-30
BACTI-SWAB(TM) II (K912831)Remel Co.1991-07-30
CHOLESTECH LIPID MONITORING SYS. (K912136)Cholestech Corp.1991-07-30
TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL (K912725)Creative Laboratory Products, Inc.1991-07-30
LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY (K912858)London Diagnostics, Inc.1991-07-30
MILENIA ESTRADIOL (K912917)Diagnostic Products Corp.1991-07-30
KITS AND TRAYS FOR ONE TIME USE ONLY (K903963)Apk Technology1991-07-29
INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE (K903962)Apk Technology1991-07-29
MICROTRAK MANAGER (K912959)Syva Co.1991-07-26
INTAVENT LARYNGEAL MASK (K904834)Intavent Intl. S.A.1991-07-26
ARTEMA AQUA+ FLEX (K912336)Artema Medical AB1991-07-26
ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST (K913024)Em Diagnostic Systems, Inc.1991-07-26
SHUR-GRIP (K912834)Inman Medical Corp.1991-07-26
MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE (K911901)Stortz1991-07-26
ARTEMA AQUA+ (K912333)Artema Medical AB1991-07-26
ROBOTIC SAMPLE PROCESSOR (K912036)Tecan U.S., Ltd.1991-07-26
3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX (K912520)3M Health Care, Ltd.1991-07-26
ARTEMA AQUA+ T & TS (K912334)Artema Medical AB1991-07-26
FORCEPS (K904723)Minto Research & Development, Inc.1991-07-26
WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 (K912826)Cala Diagnostics1991-07-26
ARTEMA AQUA+ N (K912335)Artema Medical AB1991-07-26
PLASTIC OVERLAYS (K911374)National Reading Service1991-07-26
RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA (K910304)Vitek Systems, Inc.1991-07-26
MAGNESIUM ASSAY KIT, CAT.# 100-12 (K912825)Diagnostic Chemicals, Ltd. (Usa)1991-07-26
OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER (K912522)Summit Technology, Inc.1991-07-25
TBD, LENS MEASURING DEVICE (K912134)Alcon Laboratories1991-07-25
LANDERS THREE STRUT VITRECTOMY LENS RING (K912151)Ocular Instruments, Inc.1991-07-25
GATES GLIDDEN DRILLS (K905418)The Hygenic Corp.1991-07-25
ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) (K912318)Serono-Baker Diagnostics, Inc.1991-07-25
SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID (K912665)Resound Corp.1991-07-24
ACCU-PLACER TM KIT (K912473)Hu-Friedy Mfg. Co., Inc.1991-07-24
SALTER LABS DISPOSABLE NIPPLE AND NUT (K912174)Salter Labs1991-07-24
COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS (K912489)Immuno Concepts, Inc.1991-07-24
ICON STREP B IMMUNOENZYMETRIC ASSAY (K911417)Hybritech, Inc.1991-07-24
FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS (K912488)Immuno Concepts, Inc.1991-07-24
SALTER LABS NEONATAL NASAL OXYGEN CANNULA (K911740)Salter Labs1991-07-24
TRIP(TM) NASOGASTRIC SUMP CATHETER (K911825)Tonometrics, Inc.1991-07-23
INFUSABLE (K911216)Biomedical Dynamics, Inc.1991-07-22
← Previous Next →

Track 1 automatically

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