Atlas FDA

1995

5,487 FDA 510(k) clearances · Clearance year

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RecordFirmDate
REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8 (K946060)Remington Medical, Inc.1995-04-27
RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE (K942690)Ranir/Dcp Corp.1995-04-27
ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE (K942633)Oral-B Laboratories1995-04-27
BLL-FIL 6140 PARTICLES (K950511)Bio-Interfaces, Inc.1995-04-27
RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION (K951379)Resound Corp.1995-04-27
PQ5000 CT SYSTEM (K943623)Philips Medical Systems (Cleveland), Inc.1995-04-27
ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT (K935748)Ortho Diagnostic Systems, Inc.1995-04-26
NEW-STIM SPINAL ADJUSTMENT INSTRUMENT (K944369)Lawrence E. Newsum, DC1995-04-26
IV SHUTTLE (K950367)Equipment Concepts, Inc.1995-04-26
577ES (ERGOSENSE) (K945257)Lumex, Inc.1995-04-26
ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE) (K932532)Ortho Diagnostic Systems, Inc.1995-04-26
THE BREATHER (K944412)Pal Medical, Inc.1995-04-26
ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE (K932531)Ortho Diagnostic Systems, Inc.1995-04-26
ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY (K943873)Orthomet, Inc.1995-04-26
CORDIS INTRODUCING CATHETER (K945524)Cordis Corp.1995-04-26
SELBY INSTRUMENTATION (K943775)Advanced Spine Fixation Systems, Inc.1995-04-26
ACUFEX TAG(R) BIOABSORBABLE ANCHORS (K946346)Acufex Microsurgical, Inc.1995-04-26
VANTAGE, FOR ADAC GAMMA CAMERAS (K943596)Adac Laboratories1995-04-26
SELBY INSTRUMENTATION (K945064)Advanced Spine Fixation Systems, Inc.1995-04-26
NOVOPEN 1.5 (K942159)Novo Nordisk Pharmaceuticals, Inc.1995-04-26
KIS-II STR FIXTURES (K944725)Implant Center of the Palm Beaches1995-04-26
NOPROFILE OLBERT CATHETER SYSTEM (K944989)Meadox Medicals, Div. Boston Scientific Corp.1995-04-26
ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE) (K932530)Ortho Diagnostic Systems, Inc.1995-04-26
OMNI-TRAC MODIFICATION (K935020)Invivo Research, Inc.1995-04-26
ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE) (K941713)Ortho Diagnostic Systems, Inc.1995-04-26
X2000 TRADITIONAL WHEELCHAIR (K951351)Homecrest Industries1995-04-26
ZIMMER MONOBLOC HIP PROSTHESIS WITH POLY (METHYL METHACRYLATE) (K944792)Zimmer, Inc.1995-04-26
NATURAL RUBBER LATEX SURGEONS GLOVE (K944053)Arent Fox1995-04-25
Q4.5-5.0PB-4.5 (K951342)Central Solutions, Inc.1995-04-25
EZ-RANGE (K941965)Hematronix, Inc.1995-04-25
DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI (K950817)Baxter Diagnostics, Inc.1995-04-25
ENDOPATH OPTICAL ACCESS NEEDKLE (K951444)Ethicon Endo-Surgery, Inc.1995-04-25
CLARUS NEURO ENDOSCOPE (MODEL 2230) (K941188)Clarus Medical Systems, Inc.1995-04-25
COLPOSCOPES AND ACCESSORIES (K940094)Leisegang Medical, Inc.1995-04-25
HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT (K930265)GE Medical Systems1995-04-25
CAVICIDE SURFACE DISINFECTANT/DECONTAMINANT CLEANER (K951123)Micro-Aseptic Products, Inc.1995-04-25
KARL STORZ PEDIATRIC PYLORIC SPREADER, PYLOROTOME, ENDOTOME (K951252)KARL STORZ Endoscopy-America, Inc.1995-04-25
POWDER FREE STERILE LATEX SURGEONS GLOVES (K950468)Intl. Trade Management Co.1995-04-25
PERVAL SURGICAL GOWN (MARKETING NAME) (K950504)Standard Textile Co., Inc.1995-04-25
FIKO FO;, TJER,A; O,AGER FTO-1000 (K950610)Fujifilm Medical System U.S.A., Inc.1995-04-25
BIODERM MEDICAL FOAM WOUND DRESSING (K950619)Bioderm, Inc.1995-04-25
ACCUCURE 3000 (K943411)Lasermed1995-04-25
SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES (K950464)Sscor1995-04-25
PROSHIELD PLUS MULTIPLE (K946111)Sino (U.S.A.) Co.1995-04-25
CLARUS PHOENIX ENDOSCOPE (K940144)Clarus Medical Systems, Inc.1995-04-25
BUTTON LUBRICATOR (K951713)Fibertech Instruments, Inc.1995-04-25
KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP (K951488)The Kendal Co.1995-04-25
LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD (K951328)Labeltape Meditect, Inc.1995-04-25
POWDER FREE PATIENT EXAMINATION GLOVES (K950467)Intl. Trade Management Co.1995-04-25
HEART RATE VARIABILITY SOFTWARE OPTION (K950779)Spacelabs, Inc.1995-04-25
AESCULAP LAPAROSCOPES (K942730)Aesculap, Inc.1995-04-25
MACRO SUCTION TUBE MODEL NO 10061 (K950754)Dlp, Inc.1995-04-25
OREX ISOLATION GOWN (K945223)Thantex Specialties, Inc.1995-04-25
ENDOSCOPES AND ACCESSORIES (K950612)Storz Instrument Co.1995-04-25
LUNAR EXPERT (K945526)Lunar Corp.1995-04-25
PHENO-CEN SPRAY DISINFECTANT DEODORANT (K951317)Central Solutions, Inc.1995-04-25
LEUKO-TEST (K951101)Techlab, Inc.1995-04-24
LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN (K945883)Microbiologics, Inc.1995-04-24
NAVARRE UNIVERSAL DRAINAGE CATHETER (K951475)Navarre Biomedical , Ltd.1995-04-24
DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS (K951491)Dale Medical Products, Inc.1995-04-24
DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL (K951269)Boston Surgical Products, Inc.1995-04-24
LYFO(TM) DIFFERENTIAL DISK-BILE (K945882)Microbiologics, Inc.1995-04-24
URINE REAGENT STRIPS-8 PARAMETERS (K943436)Teco Diagnostics1995-04-24
MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE (K946318)Physiometrix, Inc.1995-04-24
ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY) (K950217)American Laboratory Products Co., Ltd.1995-04-24
LYFO(TM) DIFFERENTIAL DISK-SPS (K945880)Microbiologics, Inc.1995-04-24
WESTMED BACTERIAL/VIRAL FILTER (K951484)Westmed Intl.1995-04-24
DISPOSABLE PULMONARY FUNCTION FILTER (K951410)Creative Biomedics, Inc.1995-04-24
GORE-TEX DUALMESH PLUS BIOMATERIAL (K946106)W. L. Gore & Associates, Inc.1995-04-24
GORE-TEX MYCROMESH PLUS BIOMATERIAL (K946107)W. L. Gore & Associates, Inc.1995-04-24
LYFO(TM) DIFFERENTIAL DISK-STERILE DISK (K945881)Microbiologics, Inc.1995-04-24
HI-TIP HIGH TEMPERATURE REPLACEMENT TIP (K945758)Aaron Medical Industries1995-04-21
ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY) (K950090)American Laboratory Products Co., Ltd.1995-04-21
ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY) (K950089)American Laboratory Products Co., Ltd.1995-04-21
PRO-B BIOPSY NEEDLE (K951598)Promedical , Ltd.1995-04-21
CEDIA DAU PPX/METH CALIBRATOR (K951153)Microgenics Corp.1995-04-21
CELSITE(TM) DUAL VENOUS SYSTEM (K945551)B. Braun of America, Inc.1995-04-21
ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY) (K950088)American Laboratory Products Co., Ltd.1995-04-21
SAFESHARPE (TM) DISPOSAL SYSTEM (K925056)Life Medical Technologies, Inc.1995-04-21
MODEL# 7500 SURVEYOR (K944611)Devilbiss Health Care, Inc.1995-04-21
SURETEMP (K943695)Advanced Bioresearch Assoc.1995-04-21
LYSOL I.C. BRAND DISINFECTANT (K940382)National Laboratories1995-04-21
COBAS CORE FREE T3 EIA (K942376)Roche Diagnostic Systems, Inc.1995-04-21
UROLOGICAL CATHETER & ACCESSORIES (K951178)Deroyal Industries, Inc.1995-04-21
TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (K950353)Miles, Inc.1995-04-20
ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM (K945271)Bio-Chem Laboratory Systems, Inc.1995-04-20
GIROC (K951235)Health-Dent Intl., Inc.1995-04-20
KOORDINAT M (K951176)Siemens Medical Solutions USA, Inc.1995-04-20
VIGIL MULTICHEK CONTROLS (K951170)Beckman Instruments, Inc.1995-04-20
BIONIKE A/Q PREGNANCY TEST (K951136)Charlton Assoc.1995-04-20
MARQUETTE DEFIB ELECTRODE (K941262)Marquette Electronics, Inc.1995-04-20
HP-FAST (K944903)Gi Supply1995-04-20
MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2 (K951057)Medical Analysis Systems, Inc.1995-04-20
BONE CUTTING INSTRUMENT AND ACCESSORIES (K950936)Steri-Oss, Inc.1995-04-20
QUANTITATE ENZYME VERIFIER SET (K951293)Beckman Instruments, Inc.1995-04-20
FORAMATRON IV (K950857)Parkell, Inc.1995-04-20
MRT-50 QD BODY COIL (K945875)Toshiba America Mri, Inc.1995-04-20
DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY (K931192)Dako Corp.1995-04-20
OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION (K933451)Electro-Catheter Corp.1995-04-19
MIC NASOGASTRIC-GASTROJEJUNAL FEEDING TUBE (K945612)Medical Innovations Corp.1995-04-19
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Every clearance here is in the API, with alerts when new ones post.