Atlas FDA

1999

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

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RecordFirmDate
PHASED ARRAY FLEXIBLE CARDIAC COIL (K984588)Philips Medical Systems (Cleveland), Inc.1999-02-08
SYSTEM U3 FOR AMPICILLIN (K984087)Ab Biodisk1999-02-08
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR (K983449)Gereonics, Inc.1999-02-08
ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 (K984405)Intracom Corp.1999-02-08
AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE (K984280)Hitachi Medical Systems America, Inc.1999-02-08
ACCU-CHEK HQ SYSTEM (K983047)Boehringer Mannheim Corp.1999-02-05
CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000 (K984091)Trex Medical Corp.1999-02-05
VIRILIS PENILE PROSTHESIS (K983015)Specialty Surgical Products, Inc.1999-02-05
ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT (K983694)The Binding Site, Ltd.1999-02-05
KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II (K983626)Alaris Medical Systems, Inc.1999-02-05
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005 (K984520)Nichols Institute Diagnostics1999-02-05
ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST (K983692)The Binding Site, Ltd.1999-02-05
ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT (K983695)The Binding Site, Ltd.1999-02-05
ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT (K983696)The Binding Site, Ltd.1999-02-05
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3 (K984166)Ortho-Clinical Diagnostics, Inc.1999-02-05
BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP (K983372)Sunscope Intl., Inc.1999-02-05
OMNIFLATOR 7640 MODEL 7-640-00 (K983326)Northgate Technologies, Inc.1999-02-05
PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 (K984092)Trex Medical Corp.1999-02-05
QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153 (K982938)Phamatech1999-02-05
INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING (K983596)Cook Ob/Gyn1999-02-05
HOWMEDICA HUMERAL INTERCALARY SYSTEM (K984202)Howmedica, Inc.1999-02-05
ABBOTT ARCHITECT FOLATE (K984301)Abbott Laboratories1999-02-05
MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM (K990197)Exactech, Inc.1999-02-04
CANDELA GENTLELASE II DERMATOLOGICAL LASER (K984601)Candela Corp.1999-02-04
CORE-IDE (K984037)Roydent Dental Products, Inc.1999-02-04
SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B (K984561)Msr, Inc.1999-02-04
CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS (K972719)Medicel, S.A. DE C.V.1999-02-04
GENICON TROCAR (K982472)Genicon, LC1999-02-04
DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 (K981733)Medtronic Functional Diagnostics A/S1999-02-04
BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (K984613)Albert Browne , Ltd.1999-02-04
PERFUSOR COMPACT (K983005)B.Braun Medical, Inc.1999-02-04
OSTEO-MESH TM-300 (K984230)Osteogenics Biomedical, Inc.1999-02-04
BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM (K984053)Medtronic PS Medical1999-02-04
DORNIER MEDILAS R (K984349)Dornier1999-02-04
UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED) (K983614)American Healthcare Products (M) Sdn Bhd1999-02-04
CLEARFIL SE BOND (K990040)Kuraray Co.1999-02-04
NUTRISAFE ENTERAL FEEDING TUBE (K981629)Schiff & Co.1999-02-04
MIRACLE MIX POWDER/LIQUID (K984505)GC America, Inc.1999-02-04
DIODE LASER (K982119)Esc Medical Systems , Ltd.1999-02-04
BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (K984616)Albert Browne , Ltd.1999-02-04
PANORAMIC200 OPTHALMOSCOPE (K983999)Optos Plc.1999-02-03
PRESSUREWIRE SENSOR, MODEL #12001 (K983506)Radi Medical Systems AB1999-02-03
CERALAS DIODE LASER SYSTEM (MODEL H) (K983950)Ceram Optec, Inc.1999-02-03
EDI VERIS SYSTEM (K983983)Electro-Diagnostic Imaging, Inc.1999-02-03
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED (K984209)Biomet, Inc.1999-02-03
ABBOTT ARCHITECT B12 (K984108)Abbott Laboratories1999-02-03
MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIR (K990157)Invacare Corp.1999-02-03
INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT (K983509)Sulzer Orthopedics, Inc.1999-02-03
ENDOPATH ULTRA VERESS NEEDLE (K983925)Ethicon Endo-Surgery, Inc.1999-02-03
NUMOBAG (K981949)Numotech, Inc.1999-02-03
OPTICOAT T4 EIA KIT (K982298)Biotecx Laboratories, Inc.1999-02-03
ADVANCED REVISION PRODUCT LINE EXTENSION (K990030)Wrightmedicaltechnologyinc1999-02-03
ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT (K984165)The Binding Site, Ltd.1999-02-02
WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 (K982307)Wallac, Inc.1999-02-02
MEROGEL NASAL DRESSING AND SINUS STENT (K982731)Xomed, Inc.1999-02-02
EWC: ECG II CABLE LEADWIRE SYSTEM (K984263)Ewc1999-02-02
ANTI-TPO EIA DIAGNOSTIC TEST KIT (K984163)The Binding Site, Ltd.1999-02-02
HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET (K990213)Gyrus Ent LLC1999-02-02
ELECSYS IGE CALCHECK (K984419)Boehringer Mannheim Corp.1999-02-02
ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05 (K984625)Bio-Rad1999-02-02
ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05 (K984604)Bio-Rad1999-02-02
EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA (K980631)Embol-X, Inc.1999-02-02
B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 (K990055)Omega Medical Imaging, Inc.1999-02-02
PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS (K984224)Siemens Corp.1999-02-02
XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM (K984406)Xitec, Inc.1999-02-02
OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700 (K981725)Optovent, Inc.1999-02-02
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK (K983690)Ortho-Clinical Diagnostics, Inc.1999-02-02
OSTEOMARK NTX SERUM EIA (K983457)Ostex Intl., Inc.1999-02-02
NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY (K984186)Nichols Institute Diagnostics1999-02-02
LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 (K984594)Bio-Rad1999-02-02
MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE (K990266)Micromedical Industries, Ltd.1999-02-02
IS ANTI-TPO IGG ELISA TEST SYSTEM (K984228)Columbia Bioscience, Inc.1999-02-02
QUANTEX ASO-CRP-RP CONTROL II (K984437)Instrumentation Laboratory CO1999-02-02
GUIDEWIRE (K982559)Galt Medical Corp.1999-02-01
POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER (K982385)Porous Media Corp.1999-02-01
PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452 (K984182)Possis Medical, Inc.1999-02-01
THE GOLDEN TIP ELECTRO-SURGICAL PROBE (K984275)Amada Surgical1999-02-01
KSEA HF-SNARE (K983901)KARL STORZ Endoscopy-America, Inc.1999-02-01
STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM (K990095)Influence, Inc.1999-02-01
VECTRA COMBO (K982317)Chattanooga Group, Inc.1999-02-01
C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE (K984233)Fresenius Hemotechnology, Inc.1999-02-01
OSTEONICS COMBINATION SCREW RING/BLOCKER (K990158)Osteonics Corp.1999-02-01
ZETA MULTIZONE LOCKING NAIL SYSTEM (K984305)Howmedica, Inc.1999-02-01
VECTRA STIM MODELS 200 AND 400 (K982321)Chattanooga Group, Inc.1999-02-01
COOK MINI-INCUBATOR (K983642)Cook Ob/Gyn1999-02-01
SHEER THIN (K984488)Twe Companies, Inc.1999-02-01
PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 (K984183)Possis Medical, Inc.1999-02-01
CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT (K984291)Implex Corp.1999-02-01
VECTRA PRO MODELS 2 AND 4 (K982324)Chattanooga Group, Inc.1999-02-01
MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE (K990120)Depuy Ace Medical Co.1999-02-01
BARDEX LUBRI-SIL FOLEY CATHETER (K984084)Bard Medical Div.1999-02-01
IMPLEX SCREW AND WASHER SYSTEM (K982751)Implex Corp.1999-02-01
CORSAIRE (K982750)Optiway, Inc.1999-02-01
CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G (K983897)Ri Mos. S.R.L.1999-02-01
AESCULAP XENON LIGHT SOURCE (K984124)Aesculap, Inc.1999-02-01
CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE (K983878)E. Benson Hood Laboratories, Inc.1999-01-29
AVL OMNI MODULAR ANALYZER (K990092)Avl Scientific Corp.1999-01-29
BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES (K983885)Howmedica, Inc.1999-01-29
BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS (K982947)Ocular Sciences Puerto Rico, Inc.1999-01-29
LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529 (K984477)Bio-Rad1999-01-29
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