Atlas FDA

1995

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

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RecordFirmDate
DEGUDENT U (K951778)Degussa Corp.1995-05-31
SCIMED GATEWAY PLUS (K951089)Scimed Life Systems, Inc.1995-05-31
CARDON PHYSICAL THERAPY TABLE MODEL R27112 (K951952)Cardon Rehabilitation Products, Inc.1995-05-31
CELSITE(TM) BRACHIAL VENOUS PORT (K945752)B. Braun of America, Inc.1995-05-31
CONTINUOUS FLOW BIOPSY PROBE (K942626)Gm Engineering, Inc.1995-05-30
TOTAL SHOULDER PROSTHESIS (K950651)Encore Orthopedics, Inc.1995-05-30
EPI-SPINAL ANESTHESIA TRAY (K941153)Preferred Medical Products1995-05-30
ETHICON NONABSORBABLE SUTURE ANCHOR (K943950)ETHICON, Inc.1995-05-30
FE-24X, FIBER ESOPHAGOSCOPE (K951197)Pentax Precision Instrument Corp.1995-05-30
INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT (K951896)Siemens Hearing Instruments, Inc.1995-05-30
STAR TECHNOLGIES, INC. IMAGE MANAGEMENT SERVER (K951141)Star Technologies, Inc.1995-05-30
BIRTH THEFT INFANT IDENTIFICATION AND PROTECTION UMBILICAL CORD CLAMP (K945841)W G M Corp.1995-05-30
PULMONEX DYNAMIC AIR THERAPY UNIT (K950756)Hill-Rom, Inc.1995-05-30
ALTRA NOVA(TM) 140 HEMODIALYZER (K945625)Althin Medical AB an Affiliate of Baxter Intl1995-05-30
HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT (K951967)Kent Laboratories, Inc.1995-05-30
ASE MAXI-TORQUE, SUPPLE FLEX ANGIOGRAPHIC CATHETERS (K950855)Adam Spence Corp.1995-05-30
FE-34TH, FIBER ESOPHAGOSCOPE (K951198)Pentax Precision Instrument Corp.1995-05-30
ALTRA NOVA(TM) 170 HEMODIALYZER (K945621)Althin Medical AB an Affiliate of Baxter Intl1995-05-30
DIGITAL RETINOSCOPIC PHOTOMETER (K951179)Kudi Kalu, Inc.1995-05-30
ORTHOMET TITANIUM HYBRID FEMORAL STEM (K945783)Orthomet, Inc.1995-05-30
HUMAN C1Q RADIAL IMMUNODIFFUSION KIT (K951968)Kent Laboratories, Inc.1995-05-30
SALINE SOLUTINE, STERILE (K950560)Busse Hospital Disposables, Inc.1995-05-30
CONNECTING TUBE (K951745)Vital Signs, Inc.1995-05-30
SKALPI 3200 (K946382)Wiscco Development, Inc.1995-05-30
FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE (K951191)Pentax Precision Instrument Corp.1995-05-30
SENSI-TOUCH EPIDURAL ANESTHESIA TRAY (K950929)Sherwood Medical Co.1995-05-30
HIP FIXATION SYSTEM (K950866)Medtec, Inc.1995-05-30
CUSTOM ARTIFICIAL HUMAN EYES (K945270)Daniel T Acosta1995-05-30
INSTACINE (K942558)Fidelity Medical, Inc.1995-05-30
URETHRAL CATHETERIZATION TRAY (K950390)Medcare Custom Packaging, Inc.1995-05-30
INFINITY SHOULDER SYSTEM (K943908)Wrightmedicaltechnologyinc1995-05-30
ISOLA OPEN AND CLOSED SCREWS (K944756)Acromed Corp.1995-05-30
ADVIEWER 2000 (K952188)Adp , Ltd.1995-05-30
OSTEONICS(R) CCR HIP STEM SERIES (K945574)Osteonics Corp.1995-05-30
MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS (K951324)Maxol Limited L.C.1995-05-26
ATT-300 (K944699)Health Care Mfg., Inc.1995-05-26
ALEXLAZR (K950831)Candela Laser Corp.1995-05-26
SPECTACLE SUN GLASSES (K940324)Occhiali, International Eyewear1995-05-26
GIP/MEDI-GLOBE POLYPECTOMY SNARES (K943935)Medi-Globe Corp.1995-05-26
RECONSTITUTION ACCESSOREIS (K950861)Organon, Inc.1995-05-26
ECG FAX MODEM (K941282)Hewlett-Packard Co.1995-05-26
GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE (K950311)Global Medical Products, Ltd.1995-05-26
GIP/MEDI-GLOBE PAPILLOTOME (K943629)Medi-Globe Corp.1995-05-26
AOI UNIVERSAL ULTRASONIC HANDPIECE (K950880)American Optical Corp.1995-05-26
UROTEK RE-USABLE FIBEROPTIC CABLE (K951933)Energy Life Systems Corp.1995-05-26
MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) (K952300)Midas Rex Pneumatic Tools, Inc.1995-05-26
OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES (K945262)Optus, Inc.1995-05-26
MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE (K944083)Sherwood Medical Co.1995-05-26
ARTHROSCOPIC TELESCOPES (K943052)Karl Storz Endoscopy1995-05-25
KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR (K951140)Balagan Medical, Inc.1995-05-25
LINK SADDLE PROTHESIS (K951355)Turnkey Intergration USA, Inc.1995-05-25
TEEN 100 (K945213)Aerosport, Inc.1995-05-25
KSE STEINER ELECTROMECHANIC MORCELLATOR (K946147)KARL STORZ Endoscopy-America, Inc.1995-05-25
CR PERFECT (K950142)Chimera Research & Chemical, Inc.1995-05-25
LAPAROSCOPIC CLAMP (K950702)Applied Medical Resources1995-05-25
CARDON PHYSICAL THERAPY TABLE MODEL: R27841 (K950872)Cardon Rehabilitation Products, Inc.1995-05-25
MCA(TM) 180 HEMODIALYZER (K945622)Althin Medical AB an Affiliate of Baxter Intl1995-05-25
LAPARASCOPE (K943662)Pollux Endoscopy, Inc.1995-05-25
KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP (K950961)KARL STORZ Endoscopy-America, Inc.1995-05-25
SCIMED CHOICE PT PTCA GUIDE WIRE (K950835)Scimed Life Systems, Inc.1995-05-25
GERBER NATURAL COMFORT BATTERY BREAST PUMP (K942534)Gerber Products Co.1995-05-25
COMPOLGLASS COMPOGLASS SCA (K951836)Ivoclar North America, Inc.1995-05-25
DEPUY CDH PROSTHESIS (K945844)Depuy, Inc.1995-05-25
AUDIOTECH MODEL SPI (K950963)Muskogee Regional Hearing Aid Lab1995-05-25
QUEST ANTEGRADE CARDIOPLEGIA CANNULA (K950814)Quest Medical, Inc.1995-05-25
LOWE KLEARWAY (K950763)Dr. Alan A. Lowe, Inc.1995-05-25
CONMED/ASPEN LABS COATED LAPAROSCOPIC ELECTROSURGICAL BLADES (K952204)Conmedcorp1995-05-25
LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 (K950708)Graphic Controls Corp.1995-05-25
METAL BACKED ACETABULAR COMPONENT (K950542)Encore Orthopedics, Inc.1995-05-25
SILICONE FOLEY CATHETER (K951106)Cook Urological, Inc.1995-05-25
OREX(R) O.R EQUIPMENT DRAPES (K945755)Thantex Specialties, Inc.1995-05-25
3M FILTRETE(TM) AIR FILTER MEDIA (K946225)Tagg Industries1995-05-25
ULTRA SPHERICAL AMALGAM ALLOY (K951865)Goldsmith & Revere, Inc.1995-05-25
SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE (K952098)Siemens Hearing Instruments, Inc.1995-05-25
PROSYS LEG BAG (K951945)Convatec, A Division of E.R. Squibb & Sons1995-05-25
JAI (K951513)Intl. Trade Management Co.1995-05-25
BSM-8800A BEDSIDE MONITOR (K944422)Nihon Kohden America, Inc.1995-05-24
COLTOLUX LIGHT METER (K950106)Coltene/Whaledent, Inc.1995-05-24
MINI S.F.T. (URINE PRESERVATIVE) (K943466)Cambridge Diagnostic Products, Inc.1995-05-24
NIHON KOHDEN CENTRAL NURSE STATION, CNS-8310A/CNS-8350A (K935877)Nihon Kohden America, Inc.1995-05-24
KARL STORZ ENDOVISION TRICAM, MODEL 20221101 (20221001, PAL FORMAT) COLOR TELEVISION CAMERA FOR ENDOSCOPIC PROCEDURES (K950862)Karl Storz Imaging, Inc.1995-05-24
XENON LIGHT SOURCE (K951971)Envision Medical Corp.1995-05-24
DENTAL 911 (K941066)L.A.F. Industries, Inc.1995-05-24
AIRIS (K945155)Hitachi Medical Systems America, Inc.1995-05-24
ORTHODONTIC ELASTOMERIC LAGATURE MODULE (K943419)Jon-Ko Products, Inc.1995-05-24
SINUSCOPE (K940317)Stephen Chakoff, Inc.1995-05-24
MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT (K945413)Medtronic Vascular1995-05-24
IM512P (K945792)Globus Industries1995-05-24
TEMPORARY SCREENING LEAD/ CATHETER KIT (K934939)Medtronic Vascular1995-05-24
EARCLEAR (K951596)Arisil Medical1995-05-24
RIONET HM-02 (K943808)Rockwin Corp.1995-05-24
SUNBLOCKER SUNGLASSES (K950807)Blublocker Corp.1995-05-24
SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM (K945796)Sharplan Lasers, Inc.1995-05-24
PRO'TECT (K943558)Health Sense Intl., Inc.1995-05-24
EXPERT MORPHOMERTY SOFTWARD (K950611)Lunar Corp.1995-05-24
PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT (K951883)Planmed OY1995-05-24
STRATO/INFUSAID BUTTON PORT VASCULAR ACC. SYSTEM (K951875)Strato/Infusaid, Inc.1995-05-24
NEZHAT-DORESEY PENCIL-GRIP HANDLES (K951732)American Hydro-Surgical Instruments, Inc.1995-05-24
REMOTE A'LERT (K943559)Health Sense Intl., Inc.1995-05-24
KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR (K951995)Karl Storz Endoskop GmbH1995-05-24
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Every clearance here is in the API, with alerts when new ones post.