Atlas FDA

1998

3,775 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SONY DXC-LS1 COLOR VIDEO CAMERA (K980279)Sony Medical Electronics Co.1998-04-24
ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (K980294)Guidant Corp.1998-04-24
ACCENT 16, ACCENT 22 (K980322)GE Medical Systems1998-04-24
UREA (K981123)Trace Scientific , Ltd.1998-04-24
CAPINTEC MODEL 292 ELECTROMETER (K980402)Capintec, Inc.1998-04-24
DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 (K981436)Casco Standards1998-04-24
POWDER FREE CHLORINATED GLOVES-(TEXTURED) (K981164)Pan-Century Rubber Products Sdn. Bhd.1998-04-23
ASPARTATE AMINOTRANSFERASE (AST) (K981225)Abbott Laboratories1998-04-23
STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM (K965212)Steritec Products Mfg Co, Inc.1998-04-23
MANAN GALACTOGRAPHY KIT (K980227)Medical Device Technologies, Inc.1998-04-23
THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K980376)Bayer Corp.1998-04-23
DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM (K980759)Diamedix Corp.1998-04-23
CS/3 ARRHYTHMIA WORKSTATION (K974747)Datex-Engstrom, Inc.1998-04-23
ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) (K981221)Abbott Laboratories1998-04-23
REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE (K980516)London International Group, Inc.1998-04-23
ELECSYS CALCHECK CA 125II (K981278)Roche Diagnostics GmbH1998-04-23
SERAQUEST MUMPS IGG (K980059)Quest Intl., Inc.1998-04-23
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD (K974424)Comfort Rubber Gloves Industries Sdn. Bhd.1998-04-23
PROSPECT SHIGA TOXIN MICROPLATE ASSAY (K980507)Alexon - Trend, Inc.1998-04-23
MANAN MANTA CATHETER FIXATION DISK (K981229)Medical Device Technologies, Inc.1998-04-22
FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) (K980634)Aspect Vision Care, Ltd.1998-04-22
UROLOGICAL BALLOON DILATATION CATHETER (K980795)Boston Scientific Corp1998-04-22
DUAL LUER LOCK CAP (K981318)Baxter Healthcare Corp1998-04-22
MANAN MALECOT BASKET DRAINAGE CATHETER (K981258)Medical Device Technologies, Inc.1998-04-22
MAICO MA53 (K981142)Bernafon-Maico, Inc.1998-04-22
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028 (K980851)Boston Scientific Corp1998-04-22
MICROKERATOME OR THE MATE (K974598)Howard Instruments, Inc.1998-04-22
EXCEL NEURO WORKS (K980214)Excel Tech. , Ltd.1998-04-21
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) (K981039)Sri Johani Sdn. Bhd.1998-04-21
OHMEDA EXCEL 3000 ANESTHESIA SYSTEM (K973896)Ohmeda Medical1998-04-21
OPTICAL TRACKING SYSTEM (OTS) (K974602)Radionics Software Applications, Inc.1998-04-21
DETACHABLE SLICONE BALLOON (DSB) (K965071)Target Therapeutics1998-04-21
LASERLITE DIODE SURGICAL LASER (K981090)Laserlite, LLC1998-04-21
CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE (K974371)Clk Intl., Inc.1998-04-21
IL TEST PROTEIN C (K980875)Instrumentation Laboratory CO1998-04-21
SYSTEM 7500 ABC ELECTROSURGICAL UNIT (K981220)Aspen Laboratories, Inc.1998-04-21
DETACHABLE SILICONE BALLOON (DSB) (K964488)Target Therapeutics1998-04-21
FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER (K980898)Radi Medical Systems AB1998-04-21
SLT CL MD CONTACT LASER SYSTEM (K972548)Surgical Laser Technologies, Inc.1998-04-21
DERMABLATE ER: YAG LASER SYSTEM (K980361)Aesculap-Meditec North America1998-04-21
IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT (K980855)Dpc Cirrus1998-04-21
ILAB 600 CLINICAL CHEMISTRY SYSTEM (K980757)Instrumentation Laboratory CO1998-04-21
PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES (K981035)Sims Portex, Inc.1998-04-21
NITOM LOCKING FACEBOW (K980245)Ortho Kinetics Corp.1998-04-21
CEDIA DAU MULTI-DRUG CALIBRATORS (K980853)Boehringer Mannheim Corp.1998-04-21
SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 (K980783)Irt Management Corp.1998-04-21
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) (K980667)Sigma Diagnostics, Inc.1998-04-21
OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS (K980465)Olympus America, Inc.1998-04-21
ACKERMANN SURGICAL INSTRUMENTS (K974382)Ackermann Instrumente GmbH1998-04-21
DENTEK LD 15 LASERSYSTEM (K974057)Dentek Lasersystems Produktions Ges.M.B.H.1998-04-21
FERNO HEALTHCARE RECLINE-A-BATH 2 (K980033)Ferno-Washington, Inc.1998-04-21
QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3 (K981339)Consolidated Technologies, Inc.1998-04-21
HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 (K980770)Diagnostic Chemicals , Ltd.1998-04-21
IMMULITE 2000 3RD GENERATION PSA (K974842)Diagnostic Products Corp.1998-04-21
JTECH COMMANDER AND ALGOMETER (K971407)J-Tech Medical, Inc.1998-04-20
INFUTEST 2000 INFUSION DEVICE ANALYZER (K980165)Datrend Systems, Inc.1998-04-20
HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER (K971504)J-Lloyd Medical, Inc.1998-04-20
AHMED GLAUCOMA VALVE, MODEL S3 (K980657)New World Medical, Inc.1998-04-20
POWER COINS GLOW IN THE DARK LIGATURES (K980864)Ortho Kinetics Corp.1998-04-20
ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC. (K973639)J-Lloyd Medical, Inc.1998-04-20
IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT (K961486)Ivac Medical Systems1998-04-17
SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM (K964001)Med Institute, Inc.1998-04-17
PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM (K980581)Planmeca Oy1998-04-17
VIDAR VXR LS LASER FILM DIGITIZER (K974315)Vidar Systems Corp.1998-04-17
SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS (K980199)Synthes (Usa)1998-04-17
OLDELFT DIGIDELCA (K980296)Oldelft Corp. of America1998-04-17
IV DECANTER-FLEXIBLE (K980587)Inrad1998-04-17
DUREX LATEX CONDOMS (K980204)London Intl., LLC1998-04-17
ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) (K980363)Orofacial Dynamics1998-04-16
GLADRAGS COTTON MENSTRUAL PAD (K980395)Keepers!, Inc.1998-04-16
AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE (K980305)Applied Medical Technology, Inc.1998-04-16
AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST (K981165)Germaine Laboratories, Inc.1998-04-16
PARTNERSHIP CALCAR FEMORAL COMPONENTS (K980239)Howmedica, Inc.1998-04-16
COAMATIC FACTOR VIII (K981038)Instrumentation Laboratory CO1998-04-16
STRATUS CS CKMB CALPAK (K981097)Dade Behring, Inc.1998-04-16
STRATUS CS TROP CALPAK (K981100)Dade Behring, Inc.1998-04-16
PRESS-FIT STEM (K980473)Encore Orthopedics, Inc.1998-04-16
MICROSTREAM FILLERLINE OR/EMS (K980324)Oridion Medical , Ltd.1998-04-16
AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2 (K980982)Avocet Medical, Inc.1998-04-16
MDA D-DIMER (K974776)Organon Teknika Corp.1998-04-16
PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS (K974408)Biocompatibles Eyewear, Inc.1998-04-16
STERICHEK PERACETIC ACID REAGENT STRIPS (K980164)Environmental Test Systems, Inc.1998-04-16
MITEK BTB ABSORBABLE (PLA) CROSS PIN (K974341)Mitek Products1998-04-16
SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM (K980358)Synthes (Usa)1998-04-16
PTA BALLOON CATHETER (K972800)Cook, Inc.1998-04-16
UREA NITROGEN (BUN) LIQUID REAGENT (K981106)Teco Diagnostics1998-04-16
ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST (K980736)Acon Laboratories Co.1998-04-16
HARPOON SUTURE ANCHORS (K973775)Biomet, Inc.1998-04-16
CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010 (K980356)Canadian Medical Brush, Inc.1998-04-16
MICROSTREAM FILTERLINE ICU (K980327)Oridion Medical , Ltd.1998-04-16
MICROSTREAM NASAL CANNULA FILTERLINE (K980325)Oridion Medical , Ltd.1998-04-16
MACRALP(A) ENZYME IMMUNOASSAY KIT (K971157)Strategic Diagnostics, Inc.1998-04-15
BARD BTA TRAK TEST (K971402)Bard Diagnostic Sciences,Inc.1998-04-15
PLANCON MICROLAMELLAR KERATOME EVOLUTION (K980924)Plancon Instruments1998-04-15
ND: YAG ACCESSORY FOR PHOTODERM SYSTEM (K980537)Esc Medical Systems , Ltd.1998-04-15
SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES (K981051)W. L. Gore & Associates, Inc.1998-04-15
NONWOVEN PAD (K980720)Convatec, A Division of E.R. Squibb & Sons1998-04-15
KSEA N2O ENDOFLATOR (K980134)KARL STORZ Endoscopy-America, Inc.1998-04-15
IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100 (K973562)Imex Medical Systems, Inc.1998-04-15
UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD (K980525)Marukin Shoyu Co., Ltd.1998-04-15
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