Atlas FDA

1999

3,554 FDA 510(k) clearances · Clearance year

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RecordFirmDate
AIA-PACK FOLATE ASSAY (K992365)Tosoh Medics, Inc.1999-08-10
PLANMED SOPHIE AND SOPHIE CLASSIC (K991826)Planmed OY1999-08-10
CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER (K984214)Cordis Neurovascular, Inc.1999-08-10
DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE (K984530)Metrika, Inc.1999-08-10
3M LVR SYSTEM (K991961)3M Company1999-08-09
MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES (K992138)Micromedics, Inc.1999-08-09
KRONUS OPTIQUANT THYROGLOBULIN KIT (K991720)Unchanged1999-08-09
IMMUNOCARD STAT! E. COLI O157:H7 (K990263)Meridian Diagnostics, Inc.1999-08-09
MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA (K991628)Esc Medical Systems, Inc.1999-08-09
TOUCH TEAR IGE MICROASSAY KIT (K991316)Touch Scientific, Inc.1999-08-09
CADPLAN HELIOS OPTION 6.0 (K984532)Varian Medical Systems, Inc.1999-08-09
AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA (K991890)Cogent Diagnotics , Ltd.1999-08-09
NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA (K991623)Nipro Medical Corp.1999-08-09
SAS ROTA TEST (K990842)Sa Scientific, Inc.1999-08-09
ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE (K992428)Tillotson Healthcare Corp.1999-08-09
BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE (K991715)Linvatec Corp.1999-08-06
FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES (K992040)Fiber Imaging Technologies, Inc.1999-08-06
HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL (K990666)Smith & Nephew, Inc.1999-08-06
MXU-125 OR TMX-125 (K992229)Trex Medical Corp.1999-08-06
SALTER LABS PEP DEVICE (K991788)Salter Labs1999-08-06
MACMED PAEDIATRIC INTRAMEDULLARY NAIL (K991877)Innervision, Inc.1999-08-06
VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM (K992406)Mitek Products1999-08-06
VHS SUPRACONDYLAR PLATE SYSTEM (K991806)Walter Abendschein, M.D.1999-08-06
H20- TETHERED OPTION (K992291)Grass-Telefactor Product Group1999-08-06
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM (K991284)Nidek, Inc.1999-08-06
ULTIMAX ANKLE FUSION ROD SYSTEM (K991790)Encore Orthopedics, Inc.1999-08-06
CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY (K992157)Chiron Diagnostics Corp.1999-08-05
HOFFMAN IVF-1 (K991216)(Arms) Hoffman Surgical Equipment, Ivf Division1999-08-05
MICRO-STRIP FOR MARIJUANA METABOLITES (K991516)Microdiagnostics, Inc.1999-08-05
DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE (K992017)Shanghai Antares Industries, Inc.1999-08-05
PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE. (K991845)Omnigrace , Ltd.1999-08-05
HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A (K991871)Hewlett-Packard Co.1999-08-05
ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET (K991261)Research Instruments , Ltd.1999-08-05
PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE (K991846)Omnigrace , Ltd.1999-08-05
RITEFLO SPACER (K984085)Aeromax Technologies, Inc.1999-08-05
UROSTYM BIOFEEDBACK AND STIMULATION PROBES (K990041)Laborie Medical Tech Corp.1999-08-05
MAHE INSTRUMENTS (K991426)Mahe Intl., Inc.1999-08-05
LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K992019)La Glove (M) Sdn. Bhd.1999-08-05
AUTOHDL CHOLESTEROL REAGENT SET (K992002)Pointe Scientific, Inc.,1999-08-05
MICRO-STRIP FOR PHENCYCLIDINE METABOLITES (K991505)Microdiagnostics, Inc.1999-08-05
FLEXISCOPE IQ 101 (K992362)Schoelly Fiberoptic GmbH1999-08-05
CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS (K991594)Sangstat Medical Corp.1999-08-05
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR (K991981)Alliance Rubber Products Sdn. Bhd.1999-08-05
SILGEL STC-S (K984029)Nagor , Ltd.1999-08-05
DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE (K983618)Rockwell Medical Technologies, Inc.1999-08-05
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES (K991028)Cordis Corp.1999-08-04
INTRASTENT (K991929)Intratherapeutics, Inc.1999-08-04
ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K973707)Roche Molecular Systems, Inc.1999-08-04
QUICKVUE ONE-STEP H. PYLORI II TEST (K991747)Quidel Corp.1999-08-04
VINYL POWDERED EXAM GLOVE / CAT.# 15-020 (K992289)Vitalcare Group, Inc.1999-08-04
EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) (K991903)Excel Tech. , Ltd.1999-08-04
FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS (K992275)Fresenius USA, Inc.1999-08-04
CARESIDE AMMONIA (K991371)Careside, Inc.1999-08-03
HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2 (K991569)02 Marketing Group, Inc.1999-08-03
HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM (K991652)Siemens Corp.1999-08-03
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100 (K992387)Rossmax International , Ltd.1999-08-03
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200 (K992388)Rossmax International , Ltd.1999-08-03
RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE (K990619)Rusch Intl.1999-08-03
EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX (K991642)Bertec Corp.1999-08-03
INTER-OP METASUL ACETABULAR SYSTEM (K974728)Sulzer Orthopedics, Inc.1999-08-03
SOLUSTAPLE (K991566)New Deal, S.A.1999-08-03
CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (K992126)Circon Corp.1999-08-03
N LATEX STFR REAGENT (K991157)Dade Behring, Inc.1999-08-02
QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64 (K991724)Medical Advances, Inc.1999-08-02
INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 (K991867)A.P. Total Care, Inc.1999-08-02
MEDTRONIC AVE BRIDGE STENT (K992318)Medtronic Ave, Inc.1999-08-02
INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) (K992438)Indus Medicare , Ltd.1999-08-02
DUET II GLUCOSE CONTROL MONITORING SYSTEM (K990942)Lxn Corp.1999-08-02
BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 (K991866)A.P. Total Care, Inc.1999-08-02
GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C (K991629)Ge Medical Systems, Inc.1999-08-02
TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S (K991565)Smv America1999-08-02
ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION (K991805)Acuson Corp.1999-08-02
OPART, MODEL MRT-600 (K991740)Toshiba America Mri, Inc.1999-08-02
SYNERGY SHOULDER COIL (K991765)Philips Medical Systems North America, Inc.1999-08-02
INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE (K990854)Innerdyne, Inc.1999-08-02
POWDERED LATEX STERILE SURGICAL GLOVES (K992219)Tg Medical Sdn. Bhd.1999-07-30
EMS SURFACE MOUNT SCALER (K991874)(Ems Sa) Electro Medical Systems1999-07-30
DERMAPHYLYX FOAM ISLAND DRESSING (K991933)Dermaphylyx, Inc.1999-07-30
STAPLETAC BONE ANCHOR SYSTEM (K992277)Influence, Inc.1999-07-30
CRIT-LINE MONITOR III (CLM III) (K992227)In-Line Diagnostics Corp.1999-07-30
ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBES (K992408)Oratec Interventions, Inc.1999-07-30
DENTEC LD 15 DIODE LASER (K990680)Dentek Lasersystems Produktions Ges.M.B.H.1999-07-30
FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION (K991520)Fresenius Medical Care North America1999-07-30
ULTRASOUND SCANNER, MODEL TYPE 2101 (K991937)B & K Medical A/S1999-07-30
QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENT (K992186)Conmedcorp1999-07-30
AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD (K991546)Aktina Medical Physics Corp.1999-07-30
ACIER SUTURES (K991073)Cardio Thoracic Systems1999-07-30
DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601 (K992218)Kirwan Surgical Products, Inc.1999-07-30
AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE (K992288)Tyco Intl. (Us), Inc.1999-07-30
MAMEX (K992037)Del Medical Imaging Corp.1999-07-30
LACTOSORB HAND SYSTEM (K991763)Biomet, Inc.1999-07-30
BLUNT TIP TROCAR PORT (K992353)Origin Medsystems, Inc.1999-07-30
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL. (K991968)Smith & Nephew, Inc.1999-07-30
TLC PEDIATRIC FRAME, MODEL TLC-SYS (K991523)Radionics, Inc.1999-07-30
LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS) (K992018)La Glove (M) Sdn. Bhd.1999-07-30
POLARIS DIODE LASER SYSTEM AND ACCESSORIES (K990914)Xintec Corporation1999-07-30
NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO (K991581)Zimmer, Inc.1999-07-30
ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03 (K991870)A.P. Total Care, Inc.1999-07-30
UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM (K982859)Plus Orthopedics1999-07-30
AGC V2 REVISION KNEE SYSTEM (K984054)Biomet, Inc.1999-07-30
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