Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT (K913294)Surgitek Medical Engineering Corp.1991-10-04
MEDARMOR FINGERTIP, PUNCTURE AND CUT RESISTANT GLO (K912457)Medical Armor Corp.1991-10-04
HA MCCUTCHEN SLT HIP SYSTEM (K912452)Dow Corning Wright1991-10-04
FIXATION DEVICES AND BONE PLATE (K913930)John M. Rayhack1991-10-04
PYLORITRAK (K912215)Bainbridge Laboratories, Inc.1991-10-04
MEDA CROWN SERIES (K913800)Medical Electronic Assn.1991-10-04
TSIR ANGLED ABUTMENTS (K910585)Core-Vent Corp.1991-10-04
DISPOSABLE SHOE COVER (K913628)Gem Nonwovews, Inc.1991-10-04
LAPAROSCOPIC ELECTROSURGICAL CANNULA W/RETRACTABLE (K912637)Dexide, Inc.1991-10-04
MEDI GUARD DENTAL BIB (K911944)Sancella, Inc.1991-10-04
BANDAGE COMPRESS (K912952)Cal West Trading Co.1991-10-04
MEMOSIL C.D. (K913537)Heraeus Kulzer, Inc.1991-10-04
DIMENSION-HA HIP PROSTHESIS (K912922)Kirschner Medical Corp.1991-10-04
HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION (K912979)Labeltape Meditect, Inc.1991-10-04
CONFORMING BANDAGE (K912692)Ulti-Med Intl., Inc.1991-10-04
SIMMONS PLATING SYSTEM (K910681)Smith & Nephew Richards, Inc.1991-10-04
SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION (K913038)Spacelabs, Inc.1991-10-04
CONCEPT MICROMILL (K912957)Concept, Inc.1991-10-04
GRASPER, RATCHETED (5MM X 30CM) (K913991)Northgate Technologies, Inc.1991-10-04
ELITE R 90/15 (K912741)Fischer Imaging Corp.1991-10-04
SILICONE MALE EXTERNAL CATHETER (K913524)Mentor Corp.1991-10-04
POST OPERATIVE SPONGE (K912693)Ulti-Med Intl., Inc.1991-10-04
AMSET(TM) BONE SCREW (K911768)Advanced Med/Surg, Inc.1991-10-04
COMPRESS DRESSING (K912950)Cal West Trading Co.1991-10-04
MODEL #350 SHOCK-PLATE DEFIB ADAPTOR (K911402)Cardiotronics, Inc.1991-10-03
BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000) (K910323)Uab Research Foundation1991-10-03
BIODEX,MODEL B-2000 (K913021)Biodex Corp.1991-10-03
ITM SONIC SURGERY SYSTEM (K912931)Buckman Co., Inc.1991-10-03
BIODEX SYSTEM 2,MODEL S2-S (K913020)Biodex Corp.1991-10-03
YSI MODEL 2300 STAT PLUS (K913806)Ysis, Inc.1991-10-02
PNEU-WAVE (K911574)Pneu-Mobility, Inc.1991-10-02
UNIDIRECTIONAL OCCLUDER (K913230)Welch Allyn, Inc.1991-10-02
OXYGEN MASKS 82400 & 82405 (K913455)Specialty Packaging Producs, Inc.1991-10-02
PDI PARALLEL SIDED POST KIT (K913019)Precident Corp.1991-10-02
ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST (K914068)Em Diagnostic Systems, Inc.1991-10-02
DW238 #228-34A (K913068)Ivoclar North America, Inc.1991-10-02
PATIENT LIFT AND TRANSPORT (K912769)Century Manufacturing Co.1991-10-02
N80-838 SUPRAMID EXTRA SUTURE (K912429)S. Jackson, Inc.1991-10-02
STERI-SWAB (K912731)Westlock Investments (Usa), Inc.1991-10-02
EYE BUBBLE (K912367)Aaron Medical Industries1991-10-02
DEROYAL WOUND DRESSING (K912472)Deroyal Industries, Inc.1991-10-02
PALFIQUE INLAY (K913100)Tokuyama America, Inc.1991-10-02
AMISH COUNTRY SPA (K911758)Fox Pool Corp.1991-10-02
STERILESERT(TM) CABLE AND POLE DRAPE (K913047)Arch Development Group1991-10-02
WALTER GRAPHTEK (K910972)Inomed Medizintechnik GmbH1991-10-02
DW238 #228-04B (K913069)Ivoclar North America, Inc.1991-10-02
MODULAR HIP SYSTEM (K912593)Smith & Nephew Richards, Inc.1991-10-02
THE PAN.OPTX SPORTGLASS (K913388)Panoptx, Inc.1991-10-02
SKINTEMP (K913023)Biocore1991-10-02
ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SE (K912563)Mbo Laboratories, Inc.1991-10-02
LIATEST PROTEIN S KIT (K912468)American Bioproducts Co.1991-10-02
INSTANT WARM GEL PACK (K912715)Prism Technologies, Inc.1991-10-02
FASTTECH SYSTEM II (K913892)3M Diagnostic Systems, Inc.1991-10-02
PERRY(R) DERMAGUARD(R) PLUS GLOVES (K913402)Smith & Nephew Perry1991-10-02
REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1 (K914069)Medical Analysis Systems, Inc.1991-10-02
PALFIQUE LITEPOSTERIOR (K913099)Tokuyama America, Inc.1991-10-02
HANN-VAC TM, DISPOSABLE,SUCTION CATHETER (K903480)Un-I-Med, Inc.1991-10-01
CYTOLOGY BRUSH (K913248)Annex Medical, Inc.1991-09-30
FLUX-N-ALL (K911323)Precident Corp.1991-09-30
LARYNGOSCOPE (K912905)Acorn Group, Inc.1991-09-30
SEPTOCAL CAVITY LINER (K913574)Specialites Septodont1991-09-30
SILICONE GEL SHEETING (K913140)Cui Corp.1991-09-30
AIA-PACK T-U (K913663)Tosoh Corp.1991-09-30
GAUZE COMPRESS (K912953)Cal West Trading Co.1991-09-30
INSTRUMENTARIUM MEGA4 (K912963)Instrumentarium Imaging, Inc.1991-09-30
PROLACTIN IRMA IMMUNOMAG (K914107)Pantex, Div. Bio-Analysis, Inc.1991-09-30
WHITER BITER CROWN (K913152)George M. Wilson, Dds1991-09-30
MICROTAK PLUS (K913840)Syva Co.1991-09-30
PHOENIX DIGITAL EEG SYSTEM (K911229)Dantec Medical, Inc.1991-09-30
DENTAL FLOSS (K913087)Westone Products , Ltd.1991-09-30
IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000 (K911194)Rjl Systems, Inc.1991-09-30
MEDISENSOR 2001 (K903564)Medtest Systems, Inc.1991-09-30
GAUZE SPONGE,STERILE 2'S (K912779)Keilei Intl., Inc.1991-09-30
MEMFIX SCREWS (K910427)W. L. Gore & Associates, Inc.1991-09-30
MAX-I-PROBE IRRIGATION SYSTEM (K913030)Smith & Nephew, Inc.1991-09-30
FIBRETWINS (K913603)Oral-B Laboratories1991-09-30
ENDOPATH DISPOSABLE ENDOSCOPIC MULTIFEED STAPLER (K913469)ETHICON, Inc.1991-09-30
DENTAL FLOSS (K912430)Westone Products , Ltd.1991-09-30
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE (K912754)Roche Diagnostic Systems, Inc.1991-09-27
ROCHE COBAS ARGOS 5 DIFF (K912615)Roche Diagnostic Systems, Inc.1991-09-27
KODAK EKTASCAN XLP PRELIMINARY DV2000 INTERFACE (K912454)Eastman Kodak Company1991-09-27
OPERAND LUBRICATING JELLY (K912975)General Medical Co.1991-09-27
ENDOSTAT (K914104)Laserscope1991-09-27
CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) (K913133)Bionostics, Inc.1991-09-27
CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST (K914033)Cholestech Corp.1991-09-27
HEIDELBERG RETINA TOMOGRAPH (K912891)Heidelberg Engineering1991-09-27
SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 (K912447)Medical Laser, Inc.1991-09-27
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON (K911630)Baxter Healthcare Corp1991-09-27
APR COLLAR SPACER (K912916)Intermedics Orthopedics1991-09-27
MENTOR BLACK LIGHT INJECTION STENT SET (K912060)Mentor Corp.1991-09-27
SAFEWEDGE(TM) RELIEF VALVE DEVICE (K912172)Sunscope Intl., Inc.1991-09-27
LATEX EXAMINATION GLOVES (K913409)Top Glove Sdn. Bhd.1991-09-27
SIGNA ADVANTAGE 0.5T MAGNETIC RESONANCE SYSTEM (K912539)GE Medical Systems1991-09-27
AIA-PACK CK-MB (K913298)Tosoh Corp.1991-09-27
ENZYMUN-TEST ESTRADIOL (K913162)Boehringer Mannheim Corp.1991-09-27
PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE (K911366)Medical Design & Manufacturing Corp.1991-09-27
STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO (K912852)Baxter Healthcare Corp1991-09-27
LIFELINE(R) PERSONAL RESPONSE SYSTEM (K914103)Lifeline Systems, Inc.1991-09-27
INTERSON DISPOSABLE BIOPSY NEEDLE (K911464)Interson Corp.1991-09-27
PROSPEC T/GIARDIA RAPID ASSAY (K911337)Alexon, Inc.1991-09-27
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