Atlas FDA

1999

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

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RecordFirmDate
URETHANE PICC LINE MODEL UPICS- (K992198)Cook, Inc.1999-08-27
LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA (K992236)Lysta A/S1999-08-27
DN ACUPUNTURE NEEDLES (K983800)Sedatelec1999-08-27
OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM (K991055)Howmedica Osteonics Corp.1999-08-27
IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER (K982208)Jomed Imaging , Ltd.1999-08-27
SYNTHES CERVIFIX SYSTEM (K991089)Synthes Spine1999-08-27
FLUOROPLASTIC VENTILATION TUBES (K992222)Gyrus Ent LLC1999-08-26
SILVERSTEIN MICROWICK (K991670)Micromedics, Inc.1999-08-26
ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE (K992397)Cenogenics Corp.1999-08-26
RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY (K992589)Opti-Centre Laboratories1999-08-26
URINE DRUG SCREENING CONTROL (K992395)Seracare Technology1999-08-26
THERMOFLEX SYSTEM (K991847)Argomed, Inc.1999-08-26
HEPARIN CONTROL PLASMA LEVEL 2 (K992279)Pacific Hemostasis1999-08-26
HEPARIN CONTROL PLASMA LEVEL 1 (K992278)Pacific Hemostasis1999-08-26
PICCOLO METLYTE 7 REAGENT DISC (K992140)Abaxis, Inc.1999-08-26
PASCO MIC AND MIC/ID PANELS (K991925)Pasco Laboratories, Inc.1999-08-26
HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA (K991841)Ge Medical Systems F.I. Haifa1999-08-26
OSTEOPLAST, MODEL POP200 (K991854)Interpore Cross Intl.1999-08-26
REDI-TEST PCP (K991698)Redwood Biotech, Inc.1999-08-25
N-395 PULSE OXIMETER, MODEL N-395 (K991823)Nellcor Puritan Bennett, Inc.1999-08-25
POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) (K992496)Kossan Latex Industries(M)Sdn Bhd1999-08-25
FLEXIFLO ENTERAL FEEDING TUBE (K992494)Ross Product Div. Abbott Laboratories1999-08-25
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) (K992497)Kossan Latex Industries(M)Sdn Bhd1999-08-25
SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES (K992062)Safeskin Corp.1999-08-25
MED-RX EXTENSION SETS (K990777)Benlan, Inc.1999-08-25
MINIJECT (K991888)Spartan Ultrasonics, Inc.1999-08-25
POST CEMENT HI-X (K992248)Bisco, Inc.1999-08-25
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE (K992165)Pamitex Industries Sdn Bhd1999-08-25
BIOSHIELD EXPRESS STERILIZATION WRAP (K983719)Allegiance Healthcare Corp.1999-08-25
ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM (K992663)Aloka Co., Ltd.1999-08-24
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) (K992672)Belmont Instrument Corp.1999-08-24
ATC OPTION FOR EVITA 2 DURA AND EVITA 4 (K992608)Drager, Inc.1999-08-24
TRIP TONOMETRY CATHETER, 8F (K992181)Datex-Ohmeda, Inc.1999-08-24
ROTOSNARE (K992477)Inscope, LLC1999-08-24
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS (K992349)Ortho-Clinical Diagnostics, Inc.1999-08-24
NEPTUNE WASTE MANAGEMENT SYSTEM (K990037)American Immuno Tech1999-08-24
AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA (K991942)Cogent Diagnotics , Ltd.1999-08-24
AEQUALIS SHOULDER PROSTHESIS (K980244)Tornier1999-08-23
MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA (K991896)Ge Medical Systems F.I. Haifa1999-08-23
QS DELIVERY SYSTEM (K991254)Sub-Q, Inc.1999-08-23
SCIMED IMPULSE ANGIOGRAPHIC CATHETERS (K992123)Boston Scientific Scimed, Inc.1999-08-23
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE (K992299)Pamitex Industries Sdn Bhd1999-08-23
ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM (K992470)Advanced Technology Laboratories, Inc.1999-08-23
PARSET, MODEL A10001E (K992104)Rd Medical Mfg., Inc.1999-08-23
SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM (K992644)Sirona Dental Systems GmbH1999-08-23
K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 (K991007)Katecho, Inc.1999-08-23
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD (K991559)Medline Industries, Inc.1999-08-23
BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES (K992107)General Gloves Corp.1999-08-23
MRGP OPTICAL TRACKING UNIT (K991943)Philips Medical Systems (Cleveland), Inc.1999-08-23
CHOLESITE TEST SYSTEM (K992132)Gds Technology, LLC1999-08-20
DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT (K991909)Dentsply Intl.1999-08-20
INTRAVASCULAR ADMINISTRATION SET (K991932)The Kipp Group1999-08-20
SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING (K991312)Library Medical, Inc.1999-08-20
ADVANTA GRAFT (K992443)Atrium Medical Corp.1999-08-20
RLP CHOLESTEROL IMMUNOSEPARATION ASSAY (K991083)Otsuka Pharmaceutical Co., Ltd.1999-08-20
COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET (K991985)Cook, Inc.1999-08-20
ADVANTA GRAFT (K992441)Atrium Medical Corp.1999-08-20
PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1 (K992361)Pall Medical1999-08-20
THE 3PM EGG MACHINE (DEN990005)3pm Co., Inc.1999-08-20
LACTOSORB SHEETS (K992158)Biomet, Inc.1999-08-20
MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT (K990236)Johnson & Johnson Medical, Div. of Ethicon, Inc.1999-08-20
BLULAZE (K992620)Premier Laser Systems, Inc.1999-08-20
CAPSULAR SHRINKAGE ELECTRODE (K991830)Linvatec Corp.1999-08-20
JOBST READY-TO-WEAR ARM SLEEVES (K991570)Beiersdorf-Jobt, Inc.1999-08-20
TSX PROBE, OCULAR CONTACT PROBE;TSX PROBE,OCULAR CONTACT PROBE,SMA (K992508)Instruments For Medicine and Diagnostics1999-08-19
SAS ADENO TEST (K990630)Sa Scientific, Inc.1999-08-19
GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405 (K992149)Geiger Medical Technologies, Inc.1999-08-19
MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS (K991735)General Electric Medical Systems Information Techn1999-08-19
ELECTRO-NERVE STIMULATOR TENS, MODEL LX (K990230)Biomedical Life Systems, Inc.1999-08-19
MAGNATEK 30 (K991819)Magna Advanced Technologies, Inc.1999-08-19
EBI XFIX DFS RAIL SYSTEM (K991941)Electro-Biology, Inc.1999-08-19
XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16 (K992313)Excel Tech. , Ltd.1999-08-19
POCKIT HSV 2 RAPID TEST (K983886)Diagnology , Ltd.1999-08-19
ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR (K992413)Medical Data Electronics1999-08-19
FUNNEL TROCAR (K992324)Patton Medical Corp.1999-08-19
STREP B OIA (K991828)Biostar, Inc.1999-08-19
OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2 (K992086)Olympus America, Inc.1999-08-19
VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL (K992081)Suretex Prophylactics (India) , Ltd.1999-08-19
LAPAROCAM (K992541)Karl Storz Endoscopy1999-08-19
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR (K991739)General Electric Medical Systems Information Techn1999-08-19
TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G (K991119)Invacare Corp.1999-08-19
LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 (K991664)A.P. Total Care, Inc.1999-08-19
TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR (K991892)Line One Laboratories1999-08-19
B2C HIP SYSTEM (K992490)Lepine Groupe Spa.1999-08-19
JOSTRA HL-20 TWIN PUMP (K984338)Jostra Bentley1999-08-19
MINI 6800 DIGITAL MOBILE C-ARM (K992506)Ge Dec Medical Systems1999-08-19
ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033 (K992032)Acrymed, Inc.1999-08-19
K-L-W INTRAORAL DISTRACTOR (K991875)KLS-Martin L.P.1999-08-18
UROSURGE SPIRALFLO URETERAL STENT (K992391)Urosurge, Inc.1999-08-18
PRODIGY 4 TRANSLUCENT SHADES (K992118)Sybron Dental Specialties, Inc.1999-08-18
NEXUS 2 (K992160)Sybron Dental Specialties, Inc.1999-08-18
BIPOLAR SHOULDER PROSTHESIS (K991585)Biomet, Inc.1999-08-18
SUZANNE (K990565)Nellcor Puritan Bennett, Inc.1999-08-18
CUTANEOUS (BAR) ELECTRODE (K991769)Neuro Supplies, Inc.1999-08-18
ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR (K992411)Medical Data Electronics1999-08-18
DIGITAL RING ELECTRDE (K991771)Neuro Supplies, Inc.1999-08-18
DYNA TORQ TORQUE WRENCH, TORQUE WRENCH (K991283)Micro Motors, Inc.1999-08-18
KSEA CALCUSPLIT (K992114)Karl Storz Endoscopy1999-08-18
SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE (K991273)Swemed Lab International AB1999-08-18
EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS (K991719)Medimex Holfeld GmbH & Co.1999-08-18
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