Atlas FDA

1988

4,299 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SHILEY FEMORAL ARTERIAL CANNULA (K881072)Shiley, Inc.1988-05-31
MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM (K874663)Ametek/Thermox Instruments Division1988-05-31
PAR(TM) BRAND DRUG OF ABUSE CONTROLS (K880152)Medical Analysis Systems, Inc.1988-05-31
MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE (K880930)Copper Lasersonics, Inc.1988-05-31
CONTRAST INJECTION DEVICE (K880877)Med-West, Inc.1988-05-31
ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM) (K881088)Devices For Vascular Intervention, Inc.1988-05-31
STERILE NEEDLE FOR BLOOD COLLECTION (K880746)Applied Plastics Technology, Inc.1988-05-31
RANEY CLIPS (K881265)Zimmer, Inc.1988-05-31
MSI 5000 SERIES BED (K881965)Med Service, Inc.1988-05-31
CRANIOTOME BLADE OR NEURO BLADE (K881418)Nuell Air Equipment & Hospital Supplies, Inc.1988-05-31
GAMMA GLUTAMYL TRANSFERASE REAGENT SET (K881239)Tech-Neal Scientific, Inc.1988-05-31
ABBOTT BREATH ACETONE ANALYZER (K875029)Abbott Laboratories1988-05-27
PREGNOSPIA II (K881435)Organon Teknika Corp.1988-05-27
SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL (K881655)Biomedical Research & Development Laboratories, Inc.1988-05-27
IMMPULSE T, ASSAY REAGENTS (K881214)Sclavo, Inc.1988-05-27
IQ POTASSIUM (K881440)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-05-27
GAMMA-GLUTAMYL TRANSFERASE (K881626)Tech-Co, Inc.1988-05-27
LYTENING 5 (K880917)Amdev, Inc.1988-05-27
BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P. (K881702)Biotrol, USA, Inc.1988-05-27
AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693 (K881229)Em Diagnostic Systems, Inc.1988-05-27
RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC (K880880)Reagents Applications, Inc.1988-05-27
QUIDEL PREGNANCY TEST (K881595)Quidel Corp.1988-05-27
EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95 (K881337)Em Diagnostic Systems, Inc.1988-05-27
PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II (K881258)Baxter Healthcare Corp1988-05-27
DART PHENYTOIN (K880294)Coulter Electronics, Inc.1988-05-27
IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG (K881005)Icn Biomedicals, Inc.1988-05-27
EMIT CONVENIENCE PACK: THYROXINE ASSAY (K881357)Syva Co.1988-05-27
LIQUID CHROMATO. COLUMNS (K880724)Supelco, Inc.1988-05-27
LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY (K881443)London Diagnostics, Inc.1988-05-27
LIPASE UV [TOYO] (K874027)Advocacy International, Ltd.1988-05-27
TOTAL BILIRUBIN REAGENT (K881241)Tech-Neal Scientific, Inc.1988-05-27
HDL CHOLESTEROL PRECIPITATING PROCEDURE (K881326)Data Medical Associates, Inc.1988-05-27
MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM (K875181)Marion Laboratories, Inc.1988-05-27
FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 (K881596)Medix Biotech, Inc.1988-05-27
CALCIUM (K880308)Catachem, Inc.1988-05-27
ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC) (K880692)Diagnostic Chemicals, Ltd. (Usa)1988-05-27
ACE ICPM SIDE PORTED NEEDLE (K881858)Buckman Co., Inc.1988-05-27
EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT (K881257)Immunotech Corp.1988-05-27
GDS ENZYMATIC ACETAMINOPHEN REAGENT (K880829)Gds Technology, LLC1988-05-27
MULTI-FUNCTION BLOOD GAS CONTROL (K880447)Bionostics, Inc.1988-05-27
AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT (K881373)Amersham Corp.1988-05-27
MEADOX INTRA-AORTIC GRAFT (K881283)Meadox Medicals, Div. Boston Scientific Corp.1988-05-26
CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 (K880860)Dlp, Inc.1988-05-26
STAIR VEYOR (K882091)Pride Health Care, Inc.1988-05-26
LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER (K880605)Miles Laboratories, Inc.1988-05-26
TOSHIBA DIGITAL CLINICAL THERMOMETER (K881909)Toshiba Glass Co., Ltd.1988-05-26
SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11 (K880802)Medical Engineering Corp.1988-05-26
SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 (K880801)Medical Engineering Corp.1988-05-26
BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS (K880102)Baxter Healthcare Corp1988-05-26
MICROLINE CAT #100 (K880943)Microline Pentax, Inc.1988-05-26
CHECK VALVE (K881052)Baxter Healthcare Corp1988-05-26
KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE (K880850)Kmb Medical Products Co.1988-05-26
MSI 2002 SERIES BED (K881027)Med Service, Inc.1988-05-26
HIP SAVER (K882090)Pride Health Care, Inc.1988-05-26
VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA. (K881711)Telectronics and Cordis Pacing Systems1988-05-26
LASER OPTICAL CATHETER SYSTEM (K880991)Medline Industries, Inc.1988-05-25
OCHSNER & MICRON FABRIC PATCH (K881508)Intervascular, Inc.1988-05-25
CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE (K881922)Surgipath Medical Industries, Inc.1988-05-25
PLASTIC FRAME & LENS SUNGLASS (K881419)Marketing Innovations Intl., Inc.1988-05-25
ATS NAC-PAC SET (K881949)Alpha-Tec Systems, Inc.1988-05-25
SPECTACLE, FRAME AND SUNGLASSES (K881278)Nouvelle Ligne Paris1988-05-25
STUART CANNULATED CANCELLOUS BONE FIXATION SCREW (K881327)Stuart Drug & Surgical Supply, Inc.1988-05-25
PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES (K881927)Advanced Surgical Products, Inc.1988-05-25
MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER (K880231)Ideas For Medicine, Inc.1988-05-25
MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT (K881712)Medtronic Vascular1988-05-25
MODEL 3487A PISCES EPIDURAL LEAD (K881491)Medtronic Vascular1988-05-25
SENOGRAPHE 600T AND 600TS SENIX HF (K881882)General Electric Co.1988-05-25
INTERTECH STERILE WATER FOR INHALATION (K881184)Delmed, Inc.1988-05-25
SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD (K874465)Abbott Laboratories1988-05-25
NIDEK CV-4000 (K880929)Nidek, Inc.1988-05-25
MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD (K875178)Intermedics, Inc.1988-05-25
SUNGLASSES (K881594)Transfers Intl., Inc.1988-05-25
HEPARIN COATED LUMINAL PACING CATHETER (K875337)Spectramed, Inc.1988-05-25
STOCKERT-SHILEY BUBBLE MONITOR 23-23-01 (K881006)Shiley, Inc.1988-05-24
SHARPLAN ND:YAG SURGICAL HAND APPLICATORS (K881870)Sharplan Lasers, Inc.1988-05-24
MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD (K875100)Intermedics, Inc.1988-05-24
WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER (K863395)Wescor, Inc.1988-05-24
LASER MICROMANIPULATOR (K881824)Pfizer Laser Systems1988-05-24
NEOCATH (K880887)Taris Corp.1988-05-24
8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM (K880777)Medsurg Industries, Inc.1988-05-24
NEZHAT IRRIGATION PUMP SYSTEM (K880763)Cabot Medical Corp.1988-05-24
LAMINARIA (K881312)Busse Hospital Disposables, Inc.1988-05-23
HEMOCCULT SENSITIVE TEST (K880499)Smithkline Diagnostics, Inc.1988-05-23
LIFESTYLE SOF. CARE GEL CHAIR CUSHION (K882012)Gaymar Industries, Inc.1988-05-23
ADFUSE(TM) (K881590)Healthtek, Inc.1988-05-23
THE DDI SERODOT HERPES IGG TEST KIT (K875366)Disease Detection International, Inc.1988-05-23
CHLAMYDIAZYME(TM) (K880469)Abbott Laboratories1988-05-23
TEAR VOLUME TESTS (K881515)Visionex, Inc.1988-05-23
EBNA ANTIBODY (K875170)Hillcrest Biologicals1988-05-23
STANBIO SYPHILIS RPR TEST, NO. 1170 (K880144)Stanbio Laboratory1988-05-23
C-STAT/1000 (K880876)Sonne Medical, Inc.1988-05-20
CONTAIN(TM) (K874505)Arbor Technologies, Inc.1988-05-20
EPI-SCAN SELECTIVE TISSUE CONDUCTANCE METER (K874850)Epi-Scan Corp.1988-05-20
IVAC VOLUMETRIC PUMP - MODEL 590 (K875332)Y1988-05-20
ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY (K874377)Harrington Arthritis Research Center1988-05-20
DENT SLEEVE MANOMETRIC CATHETER (K881310)Wilson-Cook Medical, Inc.1988-05-20
GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER (K880871)John Wagner Associates, Inc.1988-05-20
MONTGOMERY NERVE STIMULATOR (K880720)Boston Medical Products, Inc.1988-05-20
PORT-A-CATH PORTAL INTRODUCER FORCEPS (K881690)Pharmacia Deltec, Inc.1988-05-20
PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. (K881493)Pharmacia Deltec, Inc.1988-05-20
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