Atlas FDA

1994

5,762 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3, (K944923)Clinical Controls, Inc.1994-11-04
SMILE INTEGRATED PROPHYLAXIS PASTE RINGS (K942851)Germiphene Corp.1994-11-04
SIGMA ELITE (K936046)Penlon, Inc.1994-11-04
REPLACEMENT BATTERIES (K943632)National Custom Ent., Inc.1994-11-04
CANNABINOID EIA ASSAY (K943998)Diagnostic Reagents, Inc.1994-11-04
K-10-VS, DA-05-VS, RECORDING ELECTRODES (K941568)Medicotest, Inc.1994-11-04
PROXIDERM (TENTATIVE) (K942425)Progressive Surgical Products, Inc.1994-11-04
SIGMA GLUCOSE REAGENT (K933694)Sigma Chemical Co.1994-11-04
ETEST FOR AMPICILLIN/SULBACTAM 2/1 (K935519)Ab Biodisk North America, Inc.1994-11-04
DORSAL COLUMELLA IMPLANT (K944166)Spectrum Designs, Inc.1994-11-04
MENISCUS CHIN IMPLANT (K944164)Spectrum Designs, Inc.1994-11-04
SURE-LOCK VENTILATOR TUBING HOLDER (K944324)B&B Medical Technologies, Inc.1994-11-04
ORIGIN PIXIE STIC INTRODUCER SLEEVE (K945023)Origin Medsystems, Inc.1994-11-04
MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER (K944627)Mnlase, Inc.1994-11-03
INTERMATE XLV ELASTOMERIC INFUSION SYSTEM (K943664)Baxter Healthcare Corp1994-11-03
MODEL 220-SS LASER DELIVERY PROBE (K944628)Mnlase, Inc.1994-11-03
MODEL 230-SAC LASER DELIVERY PROBE (K944629)Mnlase, Inc.1994-11-03
JENNINGS JAVELIN (K942548)Jfi Endineering, Inc.1994-11-03
MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER (K944626)Mnlase, Inc.1994-11-03
ORAFIX SPECIAL DENTURE ADHESIVE (K943486)Smithkline Beecham Corp.1994-11-03
STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBE (K944471)Mnlase, Inc.1994-11-03
DW250 #91 (K944557)Rms Div.1994-11-03
PARADERM -585M DERMATOLOGICAL LASER (K941559)Paradigm Lasers, Inc.1994-11-03
COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES (K943776)Richard Wolf Medical Instruments Corp.1994-11-03
SEALAPEX (K944480)Sybron Dental Specialties, Inc.1994-11-03
SURGI-LINK LAPAROSCOPIC ELECTRODES (K945030)Unimed Surgical Products, Inc.1994-11-03
MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER (K944625)Mnlase, Inc.1994-11-03
BABCOCK/BOWEL CLAMP FORCEPS (K940790)Richard Wolf Medical Instruments Corp.1994-11-03
TYPE I GLASS IONOMER CEMENT (K942808)Mion International Corp.1994-11-03
CURVED ENDOPHOTOCOAGULATOR LASER PROBE (K944470)Mnlase, Inc.1994-11-03
KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES, INSERT TUBES (K944823)Karl Storz Endoskop GmbH1994-11-02
JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-680 (K944870)J. Jamner Surgical Instruments, Inc.1994-11-02
SYNCHRON CX3 DELTA (K942676)Beckman-Diagnostic Systems Group1994-11-02
MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION (K944562)Microgenics Corp.1994-11-02
SENTRY INSERTION TRAY (K942827)Sentry Medical Products, Inc.1994-11-02
TRUZONE PFM DISPOSABLE MOUTHPIECE (K944512)Monaghan Medical Corp.1994-11-02
TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL (K943422)Utak Lab, Inc.1994-11-02
MR7000 WITH TIME MANAGER SOFTWARE (TMS) (K934111)Dynatech Laboratories, Inc.1994-11-02
URINE COLLECTOR & ACCESSORIES (K945204)Nelmed Corp.1994-11-02
ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER (K942753)Researched, Novel Medical Devices (Rn/Md)1994-11-02
INFORMER PLUS (K943481)Micro-Tech Medical, Inc.1994-11-02
ENZYME-LINKED FLUORESCENT IMMUNOASSAY (K943811)Biomerieux Vitek, Inc.1994-11-02
STAT PAK (K943820)Magnum Instruments, Inc.1994-11-02
BUSSE ISOLATION AND PROCEDURAL MASKS (K940720)Busse Hospital Disposables, Inc.1994-11-02
FLUIDS PACK (K944516)Alko Diagnostic Corp.1994-11-02
BODY FLUIDS BARRIER KIT (K944545)Ani Safety, Inc.1994-11-02
SUMMIT TOTAL HIP SYSTEM (K942891)Kirschner Medical Corp.1994-11-02
MICROVASIVE INJECTION GOLD PROBE (K942301)Boston Scientific Corp1994-11-02
MAHE INSTRUMENTS (K942821)Mahe-Medizintechnik1994-11-02
KARL STORZ MONOPOLAR COAGULATING, NEDLE ELECTRODES (K944796)KARL STORZ Endoscopy-America, Inc.1994-11-02
SAS SALMONELLA H D ANTISERUM (K943400)Sa Scientific, Inc.1994-11-02
V-DELTA N (V-DELTA LOY), AUROFLUID 2PF (K944572)Metalor1994-11-02
SOLOR CARE TECHNOLOGIES CORPORATION OPIATES (K941041)Solar Technologies Corp.1994-11-02
LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR (K944688)Progressive Dynamics, Inc.1994-11-01
PEAKLOG AND DISPLAY SOFTWARE (K940836)Tamarac Systems Corp.1994-11-01
PEAKLOG AND DISPLAY SOFTWARE (K940835)Medtrac Technologies Corp.1994-11-01
SURGI-LINK BIPOLAR ELECTRODES (K944898)Unimed Surgical Products, Inc.1994-11-01
DENTAL LASER FIBER SYSTEM (K945143)Incisive Technologies, Inc.1994-11-01
MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM (K933057)Continuum Electro-Optics, Inc.1994-11-01
BENNETT X-RAY DIGITAL SPOT IMAGER (K935428)Bennett X-Ray Technologies1994-11-01
MIC DISPOSABLE SNARE (K943685)Medical Innovations Corp.1994-11-01
MODEL 130-SAC ASPIRATING ENDOPHOTOCOAGULATOR LASER (K944624)Mnlase, Inc.1994-11-01
STERILE WATER FOR IRRATION (K943833)Orion Life Systems, Inc.1994-11-01
CURVD ENDOPHOTOCOGULATOR LASER PROBE (K944472)Mnlase, Inc.1994-11-01
4-O2 JR. (CPR MOUTH BARRIER) (K945177)Eagle Health Supplies1994-11-01
THE SPACEMAKER AND THE SPACEMAKER II (K944418)General Surgical Innovations1994-11-01
REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601 (K940467)Remington Medical, Inc.1994-11-01
MODEL 110-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER (K944621)Mnlase, Inc.1994-11-01
ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES (K935429)Arbo Medical, Inc.1994-11-01
LASER DELIVERY PROBE (K944282)Mnlase, Inc.1994-11-01
PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES (K941750)Boston Scientific Corp1994-11-01
RIMECO MIDSTREAM URINE COLLECTOR (K943752)Rimeco Products, Inc.1994-11-01
OXLIFE OXYGEN CONCENTRATOR (K933081)Oxlife, Inc.1994-11-01
K3 SYSTEM (K934644)Astro-Med, Inc.1994-11-01
MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEM (K942635)Meadox Medicals, Div. Boston Scientific Corp.1994-11-01
MODEL 120-SC LASER DELIVERY PROBE (K944631)Mnlase, Inc.1994-11-01
MODEL 110-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER (K944622)Mnlase, Inc.1994-11-01
MODEL 120-SS LASER DELIVERY PROBE (K944632)Mnlase, Inc.1994-11-01
CORDIS SAVVY PTA BALLOON CATHETER (K942094)Cordis Corp.1994-11-01
BODY FAT ANALYZER MODEL TBF-105 (K930599)Tanita Corp. of America1994-11-01
THERMABOND V (K926378)Dentecon, Inc.1994-11-01
MODEL 130-SAS ASPIRATING ENDOPHOTOCOAGULATOR LASER (K944623)Mnlase, Inc.1994-11-01
OPTICAL FIBER FOR ENT APPLICATIONS (K944151)Cardiogenes1994-11-01
CLEAR BLUE ENDOSCOPIC LENS FOG RDUCTION SOLUTION & CLEANING KIT (K944776)Blue Planet Industries, Inc.1994-11-01
AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 (K933086)Helena Laboratories1994-10-31
CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL (K944247)Cala Diagnostics1994-10-31
B-D SAFE-CLIP (K943683)Becton Dickinson Consumer Products1994-10-31
FOLIC ACID (K943705)Diagnostic Products Corp.1994-10-31
AUDITORY CASSETTE (K941834)Ltmlt, Inc.1994-10-31
IMMULITE SHBG (K941797)Diagnostic Products Corp.1994-10-31
ROCHE REAGENT (K941573)Roche Diagnostic Systems, Inc.1994-10-31
CARDIOCHEX CKMB MASS MEASUREMENT CONTROL (K944246)Cala Diagnostics1994-10-31
GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR (K940979)Gen-Probe, Inc.1994-10-31
PROTECTAIDE CPR PROTECTION PACK (K942469)Protectaide, Inc.1994-10-31
CARD GUARD, MODEL CG-9000 (K924486)Card Guard Scientific Survival , Ltd.1994-10-31
HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3 (K935599)Clinical Controls, Inc.1994-10-31
RITCH NYLON SUTURE LASER LENS (K933264)Ocular Instruments, Inc.1994-10-31
DEPUY POROUS COATED GLOBAL SHOULDER (K943300)Depuy, Inc.1994-10-31
PROTECTAIDE CPR PROTECTION PACK NO. 22100 (K942468)Protectaide, Inc.1994-10-31
NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS) (K943780)Heraeus Kulzer, Inc.1994-10-31
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