Atlas FDA

1994

5,762 FDA 510(k) clearances · Clearance year

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RecordFirmDate
PARI BABY (K944152)Pari Holding Co.1994-11-18
APEX UNIVERSAL DRIVE SYSTEM (K944476)Linvatec Corp.1994-11-18
SEE-THRU SELF SEALING STERILIZATION POUCH (K940807)Asep-Pro, Inc.1994-11-18
ZEST IMPLANT ANCHOR (K925849)Zest Anchors, Inc.1994-11-18
ACRA-CUT (K944311)Acra Cut, Inc.1994-11-18
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K944651)Baxter Diagnostics, Inc.1994-11-18
PRECISION THERMOPLASTIC COMPONENETS, INC. TUBING (K944429)Precision Thermoplastic Components, Inc.1994-11-18
CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBING (K945314)Cleveland Tubing, Inc.1994-11-18
FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN (K925610)Microtek Medical, Inc.1994-11-18
PA300 (K942512)The Rival Co.1994-11-18
ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE (K942427)Envision Surgical System, Inc.1994-11-17
PROSPECT CRYPTOSPORIDIUM RAPID ASSAY (K936191)Alexon Biomedical, Inc.1994-11-17
SAS QUANT HCG URINE (K944891)Sa Scientific, Inc.1994-11-17
ISOSCAN (K944185)Isolab, Inc.1994-11-17
VERDICT OPIATES (K943712)Editek, Inc.1994-11-17
LENSCHEK (K944022)Leica, Inc.1994-11-17
MULTIDEX HYDROPHILIC WOUND DRESSING (K945000)Lange Medical Products, Inc.1994-11-17
ANNELID (K940886)Kinetic Concepts, Inc.1994-11-17
ENVISION ARTHROSCOPY VISUALIZATION SYSTEM (K943666)Envision Surgical System, Inc.1994-11-17
SERUM PROTEIN CONTROLS (K944515)Pyramid Biological Corp.1994-11-17
SENSATEC ENDOSCOPIC INSTRUMENTS (K942080)Linvatec Corp.1994-11-17
POWDER FREE SURGEON'S GLOVE (K944054)Arent Fox1994-11-17
LATEX EXAMINATION GLOVES (K944778)Pt. Haloni Jane1994-11-17
FREE-LANCE (K944948)F.F.F. Enterprises, Inc.1994-11-17
ALLROUND 4 (K944889)J.F. Jelenko & Co., Inc.1994-11-17
DISPOSABLE BIPOLAR COAGULATING FORCEPS (K942710)Boston Surgical Products, Inc.1994-11-17
AUTOPAK INSTRUMENT TRAY STERILIZATION POUCH (K932086)Ongard Meddevice Packaging, Inc.1994-11-17
VERDICT COCAINE (K943710)Editek, Inc.1994-11-17
THE PERMARIDGE MATRIX CHIN (K931500)Applied Biomaterial Technologies1994-11-17
AUTOPAK STERILIZATION POUCH (K932088)Ongard Meddevice Packaging, Inc.1994-11-17
GENTAMICIN FPIA REAGENT SET AND CALIBRATORS (K943550)Sigma Diagnostics, Inc.1994-11-17
ECONOSTAND (K943129)Sf Research Corp.1994-11-17
INSUFFLATOR TUBING WITH FILTER (K943508)Stryker Endoscopy1994-11-17
SMOOTH FIT (K941575)Hi-Tec Implants1994-11-17
HERCULITE XR & XRV (K943642)Sybron Dental Specialties, Inc.1994-11-17
FILTER, DIFFUSER (K940276)Anspach Mfg., Inc.1994-11-16
DESENTECH PLUME-EVAC SMOKE EVACUATION SYSTEM (K944030)Desentech, Inc.1994-11-16
NEEDLELESS URINE SAMPLING PORT (K944236)Kendall Healthcare Products Co. Div.Of Tyco Health1994-11-16
AIRWATCH MONITOR (K941226)Enact Health Management Systems1994-11-16
ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES (K935246)Arbo Medical, Inc.1994-11-16
KARL STORZ MONOPOLAR HIGH FREQUENCY CORDS (K945380)KARL STORZ Endoscopy-America, Inc.1994-11-16
MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AID (K944241)Magnatone Hearing Aid Corp.1994-11-16
DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET (K944338)Casco Standards1994-11-15
LITE-BLADE (K944428)Eare Consulting Service1994-11-15
DMA IRON PROCEDURE (K944462)Data Medical Associates, Inc.1994-11-15
OCL CONTOUR (K945035)M-Pact Worldwide, LLC1994-11-15
PAPER FILM (K940664)Astro Office Products, Inc.1994-11-15
ELMED LBC 50-P (K926517)Elmed, Inc.1994-11-15
ANGIOTENSIN CONVERTING ENZYME REA (K942497)American Laboratory Products Co., Ltd.1994-11-15
DYNABITE LAPAROSCOPIC FORCEPS (K944245)Portlyn Corp.1994-11-15
DANAVOX MODEL CIC (K942331)Gn Danavox, Inc.1994-11-15
SUNGLASSES AND SPECTACLE FRAMES (K944644)Hung Wai Metal Manufactory1994-11-15
DOCUMENTR AMMONIA/ETHANOLCALIBRATOR (K944639)Casco Standards1994-11-15
SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER (K943739)Mallinckrodt Medical1994-11-15
SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE (K944292)Surgical Innovations Corp.1994-11-15
DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER (K944435)Deroyal Industries, Inc.1994-11-15
ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER (K943954)Conmedcorp1994-11-15
PROCHEQ 1 & 2 (K944059)Prisma Systems1994-11-15
OPTICAL FRAMES AND SUNGLASSES (K944526)Aprilia Eyewear S.P.A.1994-11-15
DAVOL ATS (K931899)Davol, Inc.1994-11-15
EMIT 2000 DIGOXIN ASSAY (K943500)Syva Co.1994-11-15
COMPASS SOFTWARE MODULE (K944097)Widex Hearing Aid Co., Inc.1994-11-15
RETINA ANGIOGRAPH (K944261)Heidelberg Engineering1994-11-14
MODULAR CERAMIC FEMORAL HEAD (K936256)Stelkast Company1994-11-14
ARTHREX GRAFT HARVESTING KIT (K941285)Arthrex, Inc.1994-11-14
JBS SMOOTH FIXATION PIN (K940666)J.B.S., S.A.1994-11-14
SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S. (K931021)Shimadzu Medical Systems1994-11-14
MODEL 5151 (K944821)Richard Wolf Medical Instruments Corp.1994-11-14
PPM III (K940712)O-Two Systems Intl., Inc.1994-11-14
CONTINUOUS CARDIAC OUTPUT SYSTEM (K932414)Abbott Laboratories1994-11-14
REXPLUS PP3 (K944548)Rexton, Inc.1994-11-14
ULTRAPRO WORKSTATION (K942917)Ramsoft, Inc.1994-11-14
MONOJECT BONE MARROW BIOPSY TRAYS (K945109)Sherwood Medical Co.1994-11-14
BI-TEC ENDOSCOPIC BIPOLAR INSTRUMENTS (K942077)Linvatec Corp.1994-11-14
OLYMPUS SWITCHING UNIT MODEL SU-1 (K944081)Olympus America, Inc.1994-11-14
PARACENTESIS NEEDLES/CANNULAS (K945160)Tri-Med Specialties, Inc.1994-11-14
SCIMED VIPER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER (K944815)Scimed Life Systems, Inc.1994-11-14
DATEX AS/3 TM ANAESTHESIA MONITOR (K933285)Datex Division Instrumentarium Corp.1994-11-14
HOT BIOPSY FORCEPS (K943078)Intl. Medical, Inc.1994-11-14
GENERAL ANESTHESIA SYSTEM (K944949)Vital Signs, Inc.1994-11-14
ULTRASOUND PROBE DRAPE (K940151)Hydro-Med Products, Inc.1994-11-14
ROYAL PLASTIC SUNGLASSES (K944341)Royal Plastic Sarl1994-11-14
RETINA FLOWMETER (K943955)Heidelberg Engineering1994-11-14
KRONNER LAPAROSCOPIC HOLDER (K941348)Kronner Prototypes, Inc.1994-11-14
NIL (K944641)Max-Vision (H.K.)Limited1994-11-14
NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR (MODEL 90553) (K941167)Spacelabs Medical, Inc.1994-11-14
J.B.S. SELF-TAPPING THREADED PIN (K940673)J.B.S., S.A.1994-11-14
J.B.S. B.A.C. PIN (K940669)J.B.S., S.A.1994-11-14
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED (K944202)Abbott Laboratories1994-11-14
ACUTOME 2000 COLOR-CORRECTED LAPAROSCOPIC C02 LASER COUPLER AND SLEEVES (K942868)Reliant Laser Corp.1994-11-14
RETINA TOMOGRAPH AND FLOWMETER (K943956)Heidelberg Engineering1994-11-14
SNORING SENSOR (K941759)Epm Development Systems Corp.1994-11-10
COMPLETE CPR KIT (K941008)Mtm Health Products , Ltd.1994-11-10
FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE (K944063)Sigma Diagnostics, Inc.1994-11-10
VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE (K944566)Bd Becton Dickinson Vacutainer Systems Preanalytic1994-11-10
DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM (K944093)E.I. Dupont DE Nemours & Co., Inc.1994-11-10
PCA MODULAR PRIMARY/REVISION PATELLA (K940713)Howmedica Corp.1994-11-10
TRI BLOCK POLUMER GEL SHEETING (K942695)Silipos, Inc.1994-11-10
REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT (K935162)Helena Laboratories1994-11-10
NON-BREATHING VALVE (K943761)Rondex Products, Inc.1994-11-10
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Every clearance here is in the API, with alerts when new ones post.