Atlas FDA

1995

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

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RecordFirmDate
OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL (K954188)Immunotech Corp.1995-11-03
FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM (K945519)Pharmaquest Corp.1995-11-03
FLEXZAN WOUND DRESSING (K954602)Dow Hickam Pharmaceuticals, Inc.1995-11-02
ENDOPATH OPEN OR ENDOSCOPIC ELECTROSUGICAL COAGULATION & CUTTING DEVICE (K954089)Ethicon Endo-Surgery, Inc.1995-11-02
FREEDOM BATH (K952442)Grand Traverse Technologies1995-11-02
FINESSE LOW-FUSING PORCELAIN SYSTEM (K954761)Dentsply Intl.1995-11-02
LAPAROSCOPIC INSTRUMENT GROUNDING SYSTEM (K954871)Conmedcorp1995-11-02
DERMAGRAN HYDROPHILIC WOUND DRESSING (K954738)Derma Sciences, Inc.1995-11-02
APEX TUBING SET (K954440)Linvatec Corp.1995-11-02
DERMAGRAN WET DRESSING (ZINC-SALINE) (K954742)Derma Sciences, Inc.1995-11-02
AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION (K953720)Aesculap, Inc.1995-11-02
DERMAGRAN WOUND DRESSING CLEANER W/ZINC (K954743)Derma Sciences, Inc.1995-11-02
DERMAGRAN WOUND DRESSING (K954740)Derma Sciences, Inc.1995-11-02
NEXUS (K954762)Sybron Dental Specialties, Inc.1995-11-02
DERMAGRAN HYDROPHILIC OINTMENT (K954739)Derma Sciences, Inc.1995-11-02
WITT BIOMEDICAL SERIES IV (K950436)Witt Biomedical Corporation1995-11-02
SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS (K951247)Baxter Healthcare Corp1995-11-02
TOURNI-COMP (K954103)Scandinavian Medical JW AB1995-11-01
DERMAGRAN (ZINC SALINE) HYDROGEL WOUND DRESSING (K954664)Derma Sciences, Inc.1995-11-01
UNSCENTED ULTRATHIN MAXI PAD (K953668)Paragon Trade Brands, Inc.1995-11-01
DERMAGRAN WENT DRESSING (DEXTROSE-SALINE) (K954741)Derma Sciences, Inc.1995-11-01
STORZ S2060-C & DP9040 BIPOLAR CCORD ADAPTORS (K954253)Storz Instrument Co.1995-11-01
UNSCENTED MENSTRUAL PAD (K953633)Tendasoft, Inc.1995-11-01
VIROTROL IV (K954298)Blackhawk Biosystems, Inc.1995-11-01
UNSCENTED CURVED ULTRATHIN MAXI PADS (K953667)Paragon Trade Brands, Inc.1995-11-01
PRECLUDE DURA SUBSTITUTE (K953969)W. L. Gore & Associates, Inc.1995-11-01
ANALYST, MODEL DSP 300 (K950760)Heart Sounds, Inc.1995-10-31
RESTORE, THERMACELLS (HOT PACK I) (K953442)Neal Dunning Assoc., Inc.1995-10-31
INTRAMEDULLARY HIP SCREW (MODIFICATION) (K954712)Smith & Nephew Richards, Inc.1995-10-31
PROSTHETICS 4MM (K952992)Implant Center of the Palm Beaches1995-10-31
BLOOD PRESSURE CUFF 3 (K951041)Pedia Pals, Inc.1995-10-31
WIDE SCREW HA-5B, CYL-HA-5 (K952991)Implant Center of the Palm Beaches1995-10-31
PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED (K952997)Implant Center of the Palm Beaches1995-10-31
TP SCREW IMPLANT 3.75, 4.0-B5 (K952998)Implant Center of the Palm Beaches1995-10-31
HEX-FIX FIELD FIXATOR (K953397)Smith & Nephew Richards, Inc.1995-10-31
RE-USABLE MONOPOLAR NEEDLE (K953886)Chalgren Enterprises, Inc.1995-10-31
6.5MM SOLID CANCELLOUS BONE SCREW (K954485)Ace Medical Co.1995-10-31
BLOOD PRESSURE CUFF 2 (K951040)Pedia Pals, Inc.1995-10-31
ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS (K953870)Medtronic Vascular1995-10-31
IMAGYN HYSTEROSCOPE SHEATHS (K952032)Imagyn Medical, Inc.1995-10-31
OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN (K942838)Olympus America, Inc.1995-10-31
SUPERSLICK (K952700)Bivona Medical Technologies1995-10-31
SYNTHES FLEXNAIL (K953334)Synthes (Usa)1995-10-31
BLOOD PRESSURE CUFF 1 (K951039)Pedia Pals, Inc.1995-10-31
LACTOSORB BONE PIN (K953194)Biomet, Inc.1995-10-31
LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM (K953937)Apt Technology, Inc.1995-10-31
THE REIFF QUANTUM WHEELCHAIR, OR QUANTUM WHEELCHAIRS (K954568)Reif Wheelchairs and Accessories, Inc.1995-10-31
RE-USABLE CONCENTRIC NEEDLE (K953887)Chalgren Enterprises, Inc.1995-10-31
WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MM (K953000)Implant Center of the Palm Beaches1995-10-31
PEBA ANCHOR (MULTIPLE SIZES) (K951451)Orthopaedic Biosystems, Ltd.1995-10-31
CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS (K950003)Instromedix, Inc.1995-10-31
EBI X FIX DYNAFIX SYSTEM (DFS) (K953406)Electro-Biology, Inc.1995-10-31
HA/TP COATED CYLINDER IMPLANT 3.3,4.0 (K952996)Implant Center of the Palm Beaches1995-10-31
MITEK MINI ANCHOR (K936311)Mitek Surgical Products, Inc.1995-10-31
TP-4 WIDE CYLINDER IMPLANTS (K952994)Implant Center of the Palm Beaches1995-10-31
UNCOATED SCREW IMPLANT 3.75, 4.0-B5 (K952999)Implant Center of the Palm Beaches1995-10-31
WIDE SCREWS TP-5B. PROS G5, TOOLS G5 OR 17-4 SS (K952985)Implant Center of the Palm Beaches1995-10-31
TP-4K SCREW IMPLANT 3.3, 3.75, 4.0 (K953001)Implant Center of the Palm Beaches1995-10-31
BEAMER PLUS (K953081)Aspen Laboratories, Inc.1995-10-30
CRYO CHECK ABNORMAL REFERENCE CHECK I & II (K952624)Precision Biologicals, Inc.1995-10-30
AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER (K954133)American Dental Products, Inc.1995-10-30
CONNECT (K954689)Sybron Dental Specialties, Inc.1995-10-30
LASER GAS MIXTURE (K954544)Liquid Technology Corp.1995-10-30
AMERICAN DENTAL PRODDUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE PASTE WITH FLUORIDE (K954405)American Dental Products, Inc.1995-10-30
AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING (K954701)American Dental Products, Inc.1995-10-30
DERMIVIEW HYPOALLERGENIC CLEAR TAPE (K944587)Johnson & Johnson Medical, Inc.1995-10-30
THE TULIP COMPANY BRANSON STRAIGHT DISSECTOR (K952955)The Tulip Mfg. Co.1995-10-30
SILANE PRIMER (K954708)Sybron Dental Specialties, Inc.1995-10-30
INCLINOMETER (K954647)J-Tech, Inc.1995-10-30
ERGOSEAT SYSTEM (K954162)Ergo-Air, Inc.1995-10-30
COLDGEL (K953542)Prism Technologies, Inc.1995-10-30
CRYO CHECK NORMAL HUMAN REFERENCE PLASMA (K952622)Precision Biologicals, Inc.1995-10-30
PRESSORE MONITOR (K954670)Cleveland Medical Devices, Inc.1995-10-30
PEDIATRIC EUROPHYLIC FOLEY CATHETER (K954752)Regulatory & Marketing Services, Inc.1995-10-30
AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE BUILDUP BLUE PASTEE (K954408)American Dental Products, Inc.1995-10-30
THE TULIP INSULATED SCISSORS (K952899)The Tulip Mfg. Co.1995-10-30
NEEDLE OR CUTTER (K953399)Biophysic Medical, Inc.1995-10-30
THE TULIP COMPANY BRANSON ANTERIOR ELEVATOR (K952936)The Tulip Mfg. Co.1995-10-30
THE SILENCER (K954530)Silent Knights Ventures, Inc.1995-10-30
SCINITREX (POWDERED NITRILE EXAMINATION GLOVESD) (K952052)Wembley Rubber Products (M) Sdn Bhd1995-10-30
PROTEK ACETABULAR ROOF REINFORCEMENT RING (K953578)Intermedics Orthopedics1995-10-30
THE TULIP COMPANY BRANSON SOFT TISSUE RETRACTOR (K952900)The Tulip Mfg. Co.1995-10-30
PATIENT EXAMINATION GLOVES (NON-CHLORINATED POWDER FREE, NON-STERILE) (K954081)Tan Chong Rubber Gloves Sdn Bhd1995-10-30
THE TULIP COMPANY BRANSON RECURVED DISSECTOR (K952934)The Tulip Mfg. Co.1995-10-30
SCINITREX (GREEN POWDERED NITRILE EXAMINATION GLOVES) (K951921)Wembley Rubber Products (M) Sdn Bhd1995-10-30
VLV SA EF INFUSION PORT (K953791)Vlv Associates, Inc.1995-10-30
AMERICAN DENTAL PRODUCTS COMPOSITE RESIN CORE PASTE WITH FLUORIDE (K954406)American Dental Products, Inc.1995-10-30
TITANIUM DYNA-LOK SPINAL SYSTEM (K953635)Sofamor Danek USA,Inc.1995-10-30
THE TULIP INSULATED GRASPERS (K952957)The Tulip Mfg. Co.1995-10-30
AMERICAN DENTAL PRODUCTS WHITE COMPOSITE RESIN CORE PASTE WITH FLUORIDE (K954407)American Dental Products, Inc.1995-10-30
COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID (K953224)Roche Diagnostic Systems, Inc.1995-10-30
NUCLEOTOME L KIT (K942987)Surgical Dynamics, Inc.1995-10-30
LG HEX PROSTHETICS (K954539)The Implant Center of the Palm Beaches1995-10-30
IMPLANTALOY (K954702)Metalor Dental USA Corp.1995-10-30
THE TULIP COMPANY WEIL-BLAKESLEY FORCEPS (K952954)The Tulip Mfg. Co.1995-10-30
SLANT/FIN HEPA CLEAR (K953536)Amcor, Ltd.1995-10-30
THE TULIP COMPANY BRANSON DOUBLE-ENDED DISSECTOR (K952956)The Tulip Mfg. Co.1995-10-30
REDI-VU SYSTEMS (SEND & RECEIVE) (K954008)Jd Technical Services, Inc.1995-10-27
ATLAS 1.0 DIAGNOSTIC ULTRASOUND SYSTEM (K936067)Atlantis Diagnostics Intl., Inc.1995-10-27
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY (K953595)GE Medical Systems1995-10-27
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Track 1995 automatically

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