Atlas FDA

1995

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

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RecordFirmDate
NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM (K951119)American Hydro-Surgical Instruments, Inc.1995-06-13
GENERAL AND PLASTIC SURGERY PACKS (K951478)Sterile Concepts, Inc.1995-06-13
LASEVAC (K951490)D.D. Surgical, Inc.1995-06-13
RUSCH INTERNATIONAL URODYNAMIC CATHETERS (K952029)Rusch Intl.1995-06-13
SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0 (K951189)Beckman Instruments, Inc.1995-06-13
CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY (K951796)Ciba Corning Diagnostics Corp.1995-06-13
PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM (K952075)Bayer Corp.1995-06-13
OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM (K944017)Olympus America, Inc.1995-06-13
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K920186)Better Water, Inc.1995-06-13
OLYMPUS NBD TUBES (K944912)Olympus America, Inc.1995-06-13
VITAL-PORT PETITE DUAL VASCULAR ACCESS SYSTEM (K951076)Med Institute, Inc.1995-06-13
VALLEYLAB PROCISION(TM) SYSTEM (K945688)Valleylab, Inc.1995-06-13
EAR-A-GATOR (K946108)Life-Tech Intl., Inc.1995-06-13
FLEXILOG 2000 (K945069)Oakfield Instruments, Ltd.1995-06-13
ASLAN LAPRETRACT (K952264)Aslan Medical Technologies, Ltd.1995-06-12
LUHR TITANIUM ALLOY PAN FIXATION SYSTEM (K945137)Howmedica Corp.1995-06-12
CIRCULON SYSTEM STEP 1 (K951022)Convatec, A Division of E.R. Squibb & Sons1995-06-12
THE LOTECON PERSONAL CARE SYSTEM (K950191)Lotecon, Inc.1995-06-12
SHARPLAN MODEL 3100 ND:YAG SURGICAL LASER SYSTEM (K951165)Sharplan Lasers, Inc.1995-06-12
BIODERM MEDICAL TRANSPARENT FILM DRESSING (K951842)Bioderm, Inc.1995-06-12
SUTTER HAMMERTOE JOINT PROSTHESIS (K943354)Sutter Corp.1995-06-12
ACUFEX PATELLAR BONE BLOCK SIZER (K944500)Acufex Microsurgical, Inc.1995-06-12
DEGULOR S (K951788)Degussa Corp.1995-06-12
DEGULOR A (K951786)Degussa Corp.1995-06-12
SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE (K952266)Stebar Instrument Corp.1995-06-12
MEGABEAM ASPIRATING ENDOCULAR PROBE (K952340)Ceram Optec, Inc.1995-06-12
LUHR TITANIUM PAN FIXATION SYSTEM (K945139)Howmedica Corp.1995-06-12
HUMID-VENT FILTER PEDI (K952084)Gibeck, Inc.1995-06-12
PONTALLOR 3 (K951790)Degussa Corp.1995-06-12
CIRCULON SYSTEM STEP 2 (K951021)Convatec, A Division of E.R. Squibb & Sons1995-06-12
DEPALOR (K951791)Degussa Corp.1995-06-12
Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 (K945800)Diagnostic Chemicals , Ltd.1995-06-09
MEDICAL LINEAR ACCELERATOR (K935615)Accelerator Systems Intl., Inc.1995-06-09
INSULATED ELECTROSURGICAL INSTRUMENTS (K951986)KARL STORZ Endoscopy-America, Inc.1995-06-09
BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING (K950685)Bioderm, Inc.1995-06-09
DIGITEST (K950237)Parkell, Inc.1995-06-09
DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS (K951631)Bayer Corp.1995-06-09
VIDAMED 50 ELECTROSURGICAL GENERATOR, VIDAMED AEC (ADJUSTABLE ELECTROSURGICAL CARTRIDGE) ACCESSORY (K951245)Vidamed, Inc.1995-06-09
SYSMEX(TM) F-820, 520 (K945837)Sysmex Corp.1995-06-09
EMERGENCY RESPONSE SAFETY KIT (K946001)Ani Safety, Inc.1995-06-09
ABBOTT VISION GLYCATED HB, MODIFICATION (K936285)Abbott Laboratories1995-06-09
ABBOTT PROJECT I, SPECTRUM (K945566)Abbott Laboratories1995-06-09
OBSTI-HOOK (K951148)Onli1995-06-09
CORPAK GASTROSTOMY TUBE (K931921)Corpak Co.1995-06-09
SAS SALMONELLA H B ANTISERUM (K951069)Sa Scientific, Inc.1995-06-09
INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT (K946158)Incstar Corp.1995-06-09
PENT NOVA AUTOBLOCK SYRINGE (K933569)Medi-Hut Co., Inc.1995-06-09
KARL STORZ KNIVES, CURETTS, HOOKS, PROBES (K945891)KARL STORZ Endoscopy-America, Inc.1995-06-09
IL TEST DIGOXIN, PN 181761-00 (K951391)Instrumentation Laboratory CO1995-06-09
ACUFEX ENDOBUTTON PACK (K951859)Acufex Microsurgical, Inc.1995-06-09
SIMS INTERTECH HYPERINFLATION BAG SYSTEM (K952214)Intertech Resources, Inc.1995-06-08
C-THRU CORONARY GUIDE WIRE (K951109)Schneider (Europe) GmbH1995-06-08
FLEXLIFE (K952036)Mallinckrodt Medical1995-06-08
W&H 896 TOP LIGH HIGHSPEED (K944709)A-Dec, Inc.1995-06-08
LATEX PATIENT EXAMINATION GLOVE POWDER FREE (HYPOALLERGENIC) (K946257)Siam Sempermed Corp., Ltd.1995-06-08
RUSCH ENDOBRONCHIAL TUBE SETS (K951091)Rusch Intl.1995-06-08
LEIGH MED. TECH. LARYNGOSCOPE BLADE COVER (K951147)Leigh Med Tech, Inc.1995-06-08
NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS (K952421)American Hydro-Surgical Instruments, Inc.1995-06-08
ADHEROL SEPP APPLICATOR (K952007)Medi-Flex Hospital Products, Inc.1995-06-08
FIBER HEAD LIGHT FH-300 (K951337)Neitz Instruments Company, Ltd.1995-06-08
DEGUBOND 4 (K951787)Degussa Corp.1995-06-08
SURGICAL INSTRUMENT MOTOTRS AND ACCESSORIES/ATTACHMENTS (K951065)Steri-Oss, Inc.1995-06-08
PFT FILTER (K952062)Intertech Resources, Inc.1995-06-08
SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC (K952169)Intertech Resources, Inc.1995-06-08
KARL STORZ UNIDRIVE SHAVER, ARTHROSCOPY BLADES (K952192)KARL STORZ Endoscopy-America, Inc.1995-06-08
INCASE EXTENSIBLE BAG--NON-STERILE (K951420)Alpha Surgical, Inc.1995-06-08
DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME (K946209)Med-Plastics Intl., Inc.1995-06-08
HOLGRATH PLASTIC-HUB, COICAL POINT SPINAL NEEDLE (K944908)Holgrath Medical Technologies, Inc.1995-06-07
GRAHAM-FIELD ULTRASOUND LOTION (K944596)Chester Labs, Inc.1995-06-07
ULTIMA AUGMENTED UHMWPE CUP (K950563)Johnson & Johnson Professionals, Inc.1995-06-07
OSTEONICS OMNIFIT AD HIP STEM SERIES (K940715)Osteonics Corp.1995-06-07
ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES (K946237)Megadyne Medical Products, Inc.1995-06-07
NON-MYDRIATIC RETINAL CAMERA (K941234)Canon USA, Inc.1995-06-07
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT (K946159)Incstar Corp.1995-06-07
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT (K946157)Incstar Corp.1995-06-07
GRASSI GASTROJEJUNOSTOMY TUBE (K932880)Bissell Medical Products, Inc.1995-06-07
AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK (K951043)Promedic, Inc.1995-06-07
HOLGRATH PLASTIC-HUB, WHITACRE STYLE SPINAL NEEDLE (K944905)Holgrath Medical Technologies, Inc.1995-06-07
HI SONIC 2000 DIGITAL HEARING INSTRUMENT (K951678)Hearing Innovations, Inc.1995-06-07
HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY (K945748)Hycor Biomedical, Inc.1995-06-07
MRI'S ALL SILICONE GASTROSTOMY TUBE (K951489)Manufacturing & Research, Inc.1995-06-07
NASAL SEPTAL SPLINT (K952207)Smith & Nephew Richards, Inc.1995-06-07
ORTHOMET HMC FEMORAL STEM COMPONENT (K936310)Orthomet, Inc.1995-06-07
HOLGRATH PLASTIC-HUB, QUINCKE SPINAL NEEDLE (K944907)Holgrath Medical Technologies, Inc.1995-06-07
CONTRAST 7000 THERAPY SYSTEM (K943497)Burke Neutech, Inc.1995-06-07
PEREGRINE DIFFUSION LIGHT PIPE (K950529)Peregrine Surgical , Ltd.1995-06-07
HUMID-VENT MICRO (K951856)Gibeck, Inc.1995-06-07
VH-2000 (K951323)Health Care Mfg., Inc.1995-06-07
HOLGRATH PLASTIC-HUB EPIDURAL NEEDLE (K944906)Holgrath Medical Technologies, Inc.1995-06-07
SONICAID MODEL MR-63 AMBULATORY ECG RECORDER (K943862)Oxford Instruments Medical Systems1995-06-07
SENSIMATIC 500SE (K950239)Parkell, Inc.1995-06-06
SURGACTIVATOR (K951569)Deschutes Medical Products, Inc.1995-06-06
NATURAL-KNEE(R)/APOLLO(TM) KNEE (K935523)Intermedics Orthopedics1995-06-06
V-GNATHOS PLUS (K952122)Metalor Dental USA Corp.1995-06-06
ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES (K945254)Endotec, Inc.1995-06-06
PRESSUREGUARD IV (K951112)Span-America Medical Systems, Inc.1995-06-06
PRIMALLOR 2 (K951785)Degussa Corp.1995-06-06
UNIVEC NONREUSABLE LOCKING SYRINGE (K951619)Univec, Inc.1995-06-06
OSTEONICS OMNIFIT AD-HA HIP STEM SERIES (K941366)Osteonics Corp.1995-06-06
TYTIN R (K951663)Kerr Corporation (Danbury)1995-06-06
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Track 1995 automatically

Every clearance here is in the API, with alerts when new ones post.