Atlas FDA

1995

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

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RecordFirmDate
CLARITY SYSTEM II (K952080)Sonamed Corp.1995-09-19
NEURO CHANNEL ENDOSCOPE MODEL 2232 (K945633)Clarus Medical Systems, Inc.1995-09-19
GYRES 2T PRESTIGE (K945791)Elscint, Inc.1995-09-19
MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES (K952838)Standard Welders Supply Co.1995-09-19
UNICOR, INC. CORRUGATED TUBING (K953784)Unicor, Inc.1995-09-19
LUMISYS, LUMISCAN 20 (K953964)Lumisys, Inc.1995-09-18
BRANEMARK SYSTEM DRILLS AND COUNTERSINKS (K952685)Nobelpharma USA, Inc.1995-09-18
LP-12 LAPAROSCOPIC PROBE (K941935)Biosound, Inc.1995-09-18
OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS (K952888)Olympus America, Inc.1995-09-18
OUTLOOK (K945827)Philips Medical Systems (Cleveland), Inc.1995-09-18
UNICOR, INC. VENTILATOR HOSES (K953785)Unicor, Inc.1995-09-18
REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY (K953770)Rexton, Inc.1995-09-18
EPICARDIA (K952846)Medicomp, Inc.1995-09-18
PCA(R) MODULAR TOTAL KNEE TIB INSERT DUROCON BASEPLATE (K940861)Howmedica Corp.1995-09-18
WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER (K953687)Westmed Intl.1995-09-18
AMENDMENTS TO MULTIFOCUS (K951002)Oticon A/S1995-09-18
OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW (K952634)Opti-Max1995-09-18
STAR TECHNOLOGIES, INC. FILM IMAGE SCAN SYSTEM (K952914)Star Technologies, Inc.1995-09-18
PHONAK 9900 CIC (K953921)Phonak, Inc.1995-09-18
ADVANCED LASER MULTILINE SYSTEM, ALY (K952796)Advanced Laser Services Corp.1995-09-18
WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK (K953464)Westmed, Inc.1995-09-18
MED-TECH LUNG DIFFUSION MIXTURE (K953934)Medical Technical Gases Inc..1995-09-18
PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT (K951258)Pudenz-Schulte Medical Research Corp.1995-09-18
LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES (K953368)Karl Storz Endoskop GmbH1995-09-18
FLUORO CATHETER (K953950)Cmt Medical Technologies, Ltd.1995-09-18
A620 EEG (K944615)Stoelting Co.1995-09-18
K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT (K954038)Argosy Electronics1995-09-18
UHMWPE COMPONENTS-CHANGE IN PACKAGING (K940743)Depuy, Inc.1995-09-18
BRANEMARK SYSTEM OVOID & U-SHAPED BAR SYSTEM (K952886)Nobelpharma USA, Inc.1995-09-18
AUSCULATOR GPS (K953218)Lyte Industries, Inc.1995-09-18
LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM (K953926)International Enzymes, Inc.1995-09-15
DENTAL IMPLANT ENDOSSEOUS (K950066)O Co., Inc.1995-09-15
PLASTIC BLUNT CANNULA (K952976)Marquette Medical, Inc.1995-09-15
VIDEO SCOPE SYSTEM (LARYNGOSCOPE) (K944032)Jedmed Instrument Co.1995-09-15
CARDIO SERV (K951110)Hellige GmbH1995-09-15
ARTHREX SUTURE ANCHOR SCREW SYSTEM (K934327)Arthrex, Inc.1995-09-15
SUCTION/IRRIGATOR TUBING KIT (K952605)Surgical Laser Technologies, Inc.1995-09-15
HI-Q HAND INSTRUMENTS, OB/GYN USE (K944200)Olympus America, Inc.1995-09-15
GENERICUFF (K953466)Generic Medical, Inc.1995-09-15
9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS (K953386)Implant Innovations, Inc.1995-09-15
DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD (K950440)J-Lloyd Medical, Inc.1995-09-15
OXBORO-MEDICAL PIN COVERS (K952783)Oxboro Medical Intl., Inc.1995-09-15
PAINTED WEDGE & ROD BREAST BOARD (K952729)Medtec, Inc.1995-09-15
HA, TP CYLINDER, UNIHOLE (K953280)Implant Center of the Palm Beaches1995-09-15
TOMTECP90 (K950279)Tomtec Imaging Systems, Inc.1995-09-15
APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT (K950383)Randox Laboratories, Ltd.1995-09-15
PRENVAL I (K953652)Base Ten Systems, Inc.1995-09-15
UST-5268P-5 TRANSDUCER (K950607)Aloka Co., Ltd.1995-09-15
CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR) RETRACTOR/ELEVATOR (K946220)Conmedcorp1995-09-15
PTFE SYRINGE FILTER (K952918)B.Braun Medical, Inc.1995-09-15
BIOSCREW ABSORBABLE INTERFERENCE SCREW (K952831)Linvatec Corp.1995-09-15
HEAT MOISTURE EXCHANGER (K953580)Intertech Resources, Inc.1995-09-15
HA, TP CYLINDER OVAL (K953281)Implant Center of the Palm Beaches1995-09-15
APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT (K950382)Randox Laboratories, Ltd.1995-09-15
HAMEX ONE (K951029)Northern Orthopaedic Products, Inc.1995-09-15
HARVARD 2 SYRINGE PUMP (K952794)Harvard Apparatus, Inc.1995-09-15
CARDIOLIPIN IGG,M,A EIA TEST KIT (K952520)Immunoprobe, Inc.1995-09-15
MIDAS REX TELESCOPING SYSTEM (K953433)Midas Rex Pneumatic Tools, Inc.1995-09-15
SULLIVAN PASSOVER HUMIDIFER (K950582)Rescare, Inc.1995-09-15
ENDOCYTE TM (K944238)D.L. Nelson and Assoc., Inc.1995-09-15
DEXIDE ENDO-LUBE KIT (K953611)Dexide, Inc.1995-09-15
DYONICS DISPOSABLE ARTHROSCOPIC BLADES (K953695)Smith & Nephew Dyonics, Inc.1995-09-15
TRANSFEER SPIKE II (K952242)The Medi-Dose Group1995-09-15
ORTHONAIL (K952739)Orthologic Corp.1995-09-15
GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS (K952342)Cobe Renal Care, Inc.1995-09-15
WESTMED RESPIRATORY LUER ADAPTOR (K953506)Westmed Intl.1995-09-15
MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER (K952652)Medscand (Usa), Inc.1995-09-15
AES, (ANESCO EVACUATION SYSTEM) ACTIVE WASTE ANESTHETIC GAS EVACUATION SYSTEM (K945216)Anesco1995-09-15
FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE (K950044)Fukuda Denshi USA, Inc.1995-09-15
HYDROPHILIC FOAM DRESSING (K953019)Busse Hospital Disposables, Inc.1995-09-15
BIOACCESS BONE BIOPSY SYSTEM (K954151)Bioaccess, Inc.1995-09-15
MAXXUS ORTHOPAEDIC SURGICAL GLOVES (K953641)Johnson & Johnson Medical, Inc.1995-09-15
ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR (K952282)Roche Diagnostic Systems, Inc.1995-09-15
THE BAGNOLI-2 EMG SYSTEM (K945286)Delsys, Inc.1995-09-15
EBV-EA(D) IGG ELISA TEST (K940093)Gull Laboratories, Inc.1995-09-15
VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS (K953039)Dadsun Corp., Ltd.1995-09-15
PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE 3, B. IRRIGATION DRILLS, TOOLING & PREANG' (K953237)The Implant Center of the Palm Beaches1995-09-15
DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS (K946077)Hans Rudolph, Inc.1995-09-15
AQUAHAB, MODEL 120-72-101 (K945733)Aquarius Electronics, Inc.1995-09-15
LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM (K953927)International Enzymes, Inc.1995-09-15
CUFF GUARD (K952825)Bowen Medical Services, Inc.1995-09-15
PM POSITIONER (K953293)Jonathan A. Parker, D.D.S.1995-09-15
TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS ENDFIRING MODELS, WITH/OUT A STERILIZABLE INSTRUMENT TRAY (K953494)Trimedyne, Inc.1995-09-14
TAKE-APART SCISSORS (K954122)KARL STORZ Endoscopy-America, Inc.1995-09-14
FLUFF GAUZE BANDAGE, STERILE & NON-STERILE (K953810)K. W. Griffen Co.1995-09-14
ROSEBUD DISSECTOR (K953060)Medical Perspectives Corp.1995-09-14
NIDEK MODEL GYC-1500 AND GYC-2000 (K951079)Nidek, Inc.1995-09-14
CHERRY PIT DISSECTOR (K953087)Medical Perspectives Corp.1995-09-14
STORZ MVS-3201 VITRECTOMY PROBE PACK (K953575)Storz Instrument Co.1995-09-14
BLOCK(TM) ARTHROSCOPIC TOOL KIT (K946174)Johnson1995-09-14
CYLINDRICAL SPONGE (K953057)Medical Perspectives Corp.1995-09-14
ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS (K953432)Midas Rex Pneumatic Tools, Inc.1995-09-14
ROUND STICK SPONGES, FLAT STICK SPONGES (K953058)Medical Perspectives Corp.1995-09-14
ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE) (K951482)Micro-Medical Devices, Inc.1995-09-14
STORZ DP4505 VITREOUS MEMBRANE DISSECTOR (K953576)Storz Instrument Co.1995-09-14
TRIANGULAR SPONGES (K953088)Medical Perspectives Corp.1995-09-14
KITTNER DISSECTOR (K953059)Medical Perspectives Corp.1995-09-14
POWERSCULPTOR PROBES (K952755)Cardiogenes1995-09-14
CHERRY DISSECTOR (K953062)Medical Perspectives Corp.1995-09-14
W2 WRIST CPM UNIT (K950682)Toronto Medical Corp.1995-09-13
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Every clearance here is in the API, with alerts when new ones post.