Atlas FDA

1994

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

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RecordFirmDate
3P (PULMONARY PERCUSSIVE PACK) (K931988)Delta Medical Manuf, Inc.1994-10-28
TRANSPARENT ANESTHESIA FILTER (K944189)Anetec, Inc.1994-10-28
PRECISON THERMOPLASTIC COMPONENTS GAS AMPLING LINES AND CONNECTORS (K943874)Precision Thermoplastic Components, Inc.1994-10-28
MINI-OP LAPAROSCOPIC LASSO (K944784)Uresil Corp.1994-10-28
PM PUMP COMPRESSOR (K930509)Precision Medical, Inc.1994-10-28
CAMERA COVER WITH TEAR TIP (K940152)Hydro-Med Products, Inc.1994-10-28
P2 NITRILE EXAM GLOVES (K944095)Biosafety Systems, Inc.1994-10-28
CONTACT LENS (K941883)Airperm, Inc.1994-10-28
MATRX HOPE(R) 5 RESUSCITATOR (K921982)Matrix Medica, Inc.1994-10-28
PORTABLE PATIENT MONITOR (K945134)Hewlett-Packard Co.1994-10-28
P2 EXAM GLOVES (K944142)Biosafety Systems, Inc.1994-10-28
UNIVERSAL VIDEO/LASER ARM DRAPE (K934630)Hydro-Med Products, Inc.1994-10-28
MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING (K925510)Spacelabs Medical, Inc.1994-10-27
BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES (K944178)Bivona Medical Technologies1994-10-27
PHENYTOIN FPIA REAGENT SET AND CALIBRATORS (K943313)Sigma Diagnostics, Inc.1994-10-27
GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS (K943407)Becton Dickinson Microbiology Systems1994-10-27
GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION (K925909)Alicia Diagnostics, Inc.1994-10-27
SUNGLASSES (K944394)Unique Industries, Inc.1994-10-27
SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY (K941496)Solarcare, Inc.1994-10-27
IMMULITE DIGITOXIN (K943235)Diagnostic Products Corp.1994-10-27
MONOJECT SAMPLETTE SEPARATOR TUBE (K941291)Sherwood Medical Co.1994-10-27
MICROSPORIDIUM CONTROL SET (K943228)Meridian Diagnostics, Inc.1994-10-27
CARDIOCHEX (K944243)Cala Diagnostics1994-10-27
SUN EYEWEAR COMPANY, MULTIPLE BRAND NAMES (K944783)Sun Eyewear Co.1994-10-27
CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES (K945034)Conmedcorp1994-10-27
MMC AMPLIFIER (K943673)Melville Software , Ltd.1994-10-26
MULE (K934238)Penny and Giles Biometrics , Ltd.1994-10-26
PRESSURE RELIEF VALVE (K941492)Circulatory Technology, Inc.1994-10-26
ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) (K930964)Acuson Corp.1994-10-26
HOWMEDICA PREMIUM FEMORAL COMPONENT (K936127)Howmedica, Inc.1994-10-26
QUANTA LITE ENA 5 ELISA KIT (K943076)Inova Diagnostics, Inc.1994-10-25
PRO-STEP LH OVULATION PREDICTION TEST (K943252)Disease Detection International, Inc.1994-10-25
4 CHANNEL DISPENSER (K944556)Tecan U.S., Inc.1994-10-25
BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE (K944426)Princeton BioMeditech Corp.1994-10-25
SCIMED TRIGUIDE GUIDE CATHETER (K944537)Scimed Life Systems, Inc.1994-10-21
MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5) (K941579)Microtest1994-10-21
ELECTRODE, CUTANEOUS (K933801)Cadwell Laboratories, Inc.1994-10-21
DESKREM-1000 (K943459)Starkey Laboratories, Inc.1994-10-21
PROGRAM 3-CH SER HEAR AIDS W/PROGRAM FIT SYST/PRO FIT (K944078)Argosy Electronics1994-10-21
PORTAREM 2000 (K943460)Starkey Laboratories, Inc.1994-10-21
ACUSON MODEL 2001 (K934915)Acuson Corp.1994-10-21
R AND D BATTERIES (K935427)R & D Batteries, Inc.1994-10-21
RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES (K926463)Midmark Corp.1994-10-21
CEDIA DAU AMPHETAMINES ASSAY (K943993)Microgenics Corp.1994-10-21
ALOKA SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM MODIFICATION (K941652)Aloka Co., Ltd.1994-10-21
PHILIPS TOMOSCAN SR5000 (K944326)Philips Medical Systems North America, Inc.1994-10-21
MION 525 (K926376)Mion International Corp.1994-10-21
IMPULSE SEALER PRODUCT LINE (K943370)Ultradent Products, Inc.1994-10-21
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION (K944723)Alamar Biosciences, Inc.1994-10-21
MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR (K943784)Menicon Co, Ltd.1994-10-20
REDA LAPAROSCOPIC INSTRUMENTS GER-MAIN PRIME ENDO LAPAROSCOPIC INSTRUMENTS (K944706)Reda Instrumente GmbH1994-10-20
LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE (K943732)Graphic Controls Corp.1994-10-20
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) (K942610)Eastman Kodak Company1994-10-20
CEDIA T4 MAB ASSAY (K943019)Microgenics Corp.1994-10-20
TRACKER 2/TRACKER 3 HOLTER RECORDER (K943278)Reynolds Medical , Ltd.1994-10-20
MRX MICROPLATE READER (K943701)Dynatech Laboratories, Inc.1994-10-20
FEDELITY F495, VIENNATONE ALPP II (K943687)Starkey Laboratories, Inc.1994-10-20
DFS-2100 (K932760)Dba Systems, Inc.1994-10-20
AVL OPTI PH/BLOOD GAS ANALYZER (K944089)Avl Scientific Corp.1994-10-20
CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS (K932776)Exactech, Inc.1994-10-20
MAC-LAB ELECTROPHYSIOLOGY MODULE OPTION (K935394)Marquette Electronics, Inc.1994-10-20
SSA-380A (K933743)Toshiba America Medical Systems, In.C1994-10-20
SEALITE SCIENCE, INC. AQUALITE(R) LH (K943188)Sealite Sciences, Inc.1994-10-20
ANTERIOR SPINE SYSTEM (K934429)Buckman Co., Inc.1994-10-20
UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS (K943960)Miracle-Ear, Inc.1994-10-20
SAFESTART VASCULAR ACCESS START KIT (K943941)Becton Dickinson Vascular Access, Inc.1994-10-20
DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD (K943996)Dupont Medical Products1994-10-20
INFLATABLE RETENTION CUFF SPECULUM (K941391)Innovatec Medical Corp.1994-10-20
WIDEX MODEL LX-ITE (K944838)Widex Hearing Aid Co., Inc.1994-10-20
MULTIPLE ED1600 SERIES RADIATION SHIELDS (K944772)Image Diagnostics, Inc.1994-10-20
IMAGYN LAPAROSCOPIC INSTRUMENTS (K944129)Imagyn Medical, Inc.1994-10-20
COHORT AVB RETRACTOR SYSTEM (K943472)Cohort Medical Products Group, Inc.1994-10-20
EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT (K935726)Exactech, Inc.1994-10-20
CARPAL BOX (K936087)Innovative Medical Technologies, Inc.1994-10-20
BELTONE CONCERTO S (K944502)Beltone Electronics Corp.1994-10-20
DMA GLUCOSE (OXIDASE) PROCEDURE (K943241)Data Medical Associates, Inc.1994-10-20
SIGMA 8000 AND SIGMA 8002 (K942162)Sigma Intl.1994-10-20
N LATEX RF (K942328)Behring Diagnostics, Inc.1994-10-20
HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE (K941765)Tcpi, Inc.1994-10-20
HOWMEDICS DRG FEMORAL COMPONENT (K936126)Howmedica, Inc.1994-10-20
ALSA-KLENZ (K944494)Calgon Vestal Div.1994-10-19
LATEX EXAM GLOVES (K941787)P.T. Irama Dinamika Latex1994-10-19
INNOVASIVE SUTURE BONE FASTENER WITH SUTURE (K935321)Innovasive Devices, Inc.1994-10-19
SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE (K944738)Ducker CL1994-10-19
CHROMOPHARE (K944855)Berchtold Holding GmbH1994-10-19
J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE (K935113)J.B.S., S.A.1994-10-19
AIMS CANNULATED ACL SCREW (K943539)Smith & Nephew, Inc.1994-10-19
DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL (K934323)Baxter Diagnostics, Inc.1994-10-19
MEMOTHERM 10 BABY THERMOMETER (K935280)International Regulatory Consultants1994-10-19
PASCO MIC AND MIC/ID PANELS (K944517)Pasco Laboratories, Inc.1994-10-19
MEDICAL SUPPORT STOCKINGS 2001/2002 (K943734)Julius Zorn, Inc.1994-10-19
NEUROLOGY ACCESSORIES - MARK-EASY 10-20 (K942461)Optimit USA, Inc.1994-10-19
MS CLASSIQUE BALLOON CATHETER (K942293)Meadox Medicals, Div. Boston Scientific Corp.1994-10-18
MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYST (K944560)KLS-Martin L.P.1994-10-18
MEDTRONIC EVEREST INFLATION DEVICE (K942269)Medtronics Interventional Vascular1994-10-18
FLEXIBLE FIBER OPTIC LAPAROSCOPES (K943598)Optimed Technologies, Inc.1994-10-18
OPTI-PLAST ANGIOPLASTY CATHETER (K941706)Vas-Cath, Inc.1994-10-18
PROTECTAIDE PERSONAL PROTECTION PACK NO. 08315 (K942470)Protectaide, Inc.1994-10-18
IMPLANTECH TEMPORAL IMPLANT (K943644)Implantech Associates, Inc.1994-10-18
PROTECTAIDE PERSONAL PROTECTION PACK NO. 24592 (K942473)Protectaide, Inc.1994-10-18
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