Atlas FDA

1995

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

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RecordFirmDate
APPLIED MEDICAL OPTICAL VALVULOTOME (K945591)Applied Medical Resources1995-02-10
MC INFANT CARE UNIE #PP30 (K950059)Janco Consulting Services1995-02-10
ORTHOVITA BIOGRAN (K941780)Orthovita Co.1995-02-10
ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BLOOD GAS ANALYZERS (K945966)Alko Diagnostic Corp.1995-02-10
BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B (K950051)The Brewer Co.1995-02-10
CARDON PHYSICAL THERAPY TABLE MODEL R28535 (K950360)Cardon Rehabilitation Products, Inc.1995-02-10
CARDON PHYSICAL THERAPY TABLES R27635 (K950364)Cardon Rehabilitation Products, Inc.1995-02-10
QUICK CHECKER HCG PREGNANCY TEST (K943859)Mizuho USA, Inc.1995-02-10
ACE IRON REAGENT (K944911)Schiapparelli Biosystems, Inc.1995-02-10
CARDON PHYSICAL THERAPY TABLE R28575 (K950361)Cardon Rehabilitation Products, Inc.1995-02-10
VALLEYLAB COATED ELECTRODES (K950188)Valleylab, Inc.1995-02-10
CLENSICAIR LOW AIRLOSS HYDROTHERAPY (K941610)Support Systems Intl.1995-02-10
MONARCH AP(TM) (K943597)Merit Medical Systems, Inc.1995-02-10
BAXTER HANDLE MODEL 1150 (K944214)Baxter Edwards1995-02-10
PHENOBARBITAL ENZYME IMMUNOASSAY (K946210)Diagnostic Reagents, Inc.1995-02-10
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #23094 (K944155)Playtex Products, Inc.1995-02-09
ARGUS LAPAROSCOPY INSTRUMENT SYSTEM (K950378)Argus Medical Co., Inc.1995-02-09
THE NOMOS CRANE (K941927)Nomos Corp.1995-02-09
OGDEN ANCHOR-SMALL (TENTATIVE) (K941029)American Medical Electronics, Inc.1995-02-09
ISOLA ANTERIOR SYSTEM (K943819)Acromed Corp.1995-02-09
OLYMPUS 5FR SEMI-RIGID SCISSORS FOR OB/GYN (K950036)Olympus America, Inc.1995-02-09
REMOTE CONTROL RADIOISOTOPE APPLICATOR (K943109)Inter-Pal GmbH1995-02-09
PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL (K945682)Gendex Corp.1995-02-09
ANGIO II (K945397)Philips Medical Systems (Cleveland), Inc.1995-02-09
COOL/HEAT THERAPY APPLICATOR (K944447)Medical Science Technology, Inc.1995-02-09
TOTALLY COOL(TM) TC-1 (K943844)Electro Science Technologies, Inc.1995-02-09
CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES) (K945603)Headwaters, Inc.1995-02-09
KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES (K944862)KARL STORZ Endoscopy-America, Inc.1995-02-09
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894 (K944064)Playtex, Inc.1995-02-09
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE (K950198)United States Surgical, A Division of Tyco Healthc1995-02-09
VIVALINK AED DEFIBRILLATOR (K940445)Survivalink Corp.1995-02-09
POET IQ WITH FIVE AGENT CAPABILITY (K942737)Criticare Systems, Inc.1995-02-09
ACUFEX TAG ANCHOR (K934867)Acufex Microsurgical, Inc.1995-02-09
LIBERTY (K943250)Utah Medical Products, Inc.1995-02-09
EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY (K932690)Exactech, Inc.1995-02-09
ALLEVYN ADHESIVE (K945330)Smith & Nephew United, Inc.1995-02-09
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22994 (K944154)Playtex Products, Inc.1995-02-09
EBICE (K945067)Electro-Biology, Inc.1995-02-09
TOTALLY COOL(TM) TC-2 (K942882)Electro Science Technologies, Inc.1995-02-09
HMT ALEXCOPE (K941013)Servicetrends, Inc.1995-02-09
NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (K942580)Neoprobe Corp.1995-02-09
SUMMIT MECHANICAL WHEELCHAIR (K946195)Summit Durable Medical Equipment, Inc.1995-02-09
KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES (K946148)KARL STORZ Endoscopy-America, Inc.1995-02-09
4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION (K945495)Fiberoptic Sensor Technlogies, Inc.1995-02-09
VANGUARD SERIES GAS REGULATORS (K942751)Buckman Co., Inc.1995-02-09
MINIMUFFS (K935160)Natus Medical, Inc.1995-02-09
LORACARBEF GRAM-NAGATIVE PANELS (K940917)Baxter Diagnostics, Inc.1995-02-08
SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIES (K944677)Scimed Peripheral Interventions1995-02-08
DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE (K945171)Boston Surgical Products, Inc.1995-02-08
ADVANTX 1824 SPOTFILM DEVICE (K950317)GE Medical Systems1995-02-08
MAGIC EAR, ELAIN (K942107)Novaplex, Inc.1995-02-08
NEUROSEARCH-4 (K920038)Lexicor1995-02-08
STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA (K944372)Solarcare, Inc.1995-02-08
NEUROSEARCH-24 OR NRS-24 (K915820)Lexicor Medical Technology, Inc.1995-02-08
PLUM XL INFUSION PUMP (K944733)Abbott Laboratories1995-02-08
VIP (K950080)Bell Hearing Instruments, Inc.1995-02-08
SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096) (K944816)Philips Medical Systems (Cleveland), Inc.1995-02-08
CATALOGUE NUMBER 321-07/15/50 (K945243)Diagnostic Chemicals , Ltd.1995-02-08
ACCESS(TM) COMPASS BED (K946244)Toshiba America Mri, Inc.1995-02-08
FOUNDATION KNEE AUGMENTATION BLOCKS (K941306)Encore Orthopedics, Inc.1995-02-08
APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT (K934381)Intermedics Orthopedics1995-02-08
MICROBORE EXTENSION SET (K942349)Excelsior Medical Corp.1995-02-08
NOVA XM2 (K932356)Dynarad Corp.1995-02-08
EBI ANTERIOR CERVICAL SPINE SYSTEM (K943694)Electro-Biology, Inc.1995-02-08
3M PEDIATRIC LAPAROTOMY SHEET #7938/ #7938NS (K946024)3M Healthcare1995-02-08
RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE (K950319)Resound Corp.1995-02-08
IMMUCHEM PHE-MW EA (K926106)Icn Biomedicals, Inc.1995-02-08
NOVA 16 ANALYZER (K945584)Nova Biomedical Corp.1995-02-08
LIQUISPEX(TM) URINE ETHANOL CONTROL (K946144)Clinical Controls, Inc.1995-02-08
QUIKPAC II, ONE STEP HCG COMBO KIT (K945951)Syntron Bioresearch, Inc.1995-02-08
THE OMNIGUIDE GUIDING CATHETER WITH BALLOON (K945963)Micro Interventional Systems, Inc.1995-02-08
TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II (K940817)Abbott Laboratories1995-02-08
GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH CONFIRMATION HELMET(DH-1) (K934523)Radionics, Inc.1995-02-08
INTRAVASCULAR ADMINISTRATION SET (K945184)Distronic Sterile Products, Inc.1995-02-08
UREA NITROGEN REAGENT (K944250)Olympus Corp of America1995-02-08
GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM) (K945689)Calmed Technology, Inc.1995-02-08
LIFESIGN MI MYOGLOBIN (K942052)Princeton Biomedix1995-02-07
VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) (K944671)Jedmed Instrument Co.1995-02-07
WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR (K944664)Wako Chemicals USA, Inc.1995-02-07
PREPPIES SKIN BARRIER WIPE (K945675)Kendall Healthcare Products Co. Div.Of Tyco Health1995-02-07
ROSE K LENS (K945955)Rose K International , Ltd.1995-02-07
KARL STORZ BOUGIES AND DILATORS (K950125)KARL STORZ Endoscopy-America, Inc.1995-02-07
IVR MASTER (K945389)Shimadzu Corp.1995-02-07
SUNGLASSES (K950079)Gianni Versace1995-02-07
PREMIE U-BAG URINE SPECIMEN COLLECTOR (K950176)Hollister, Inc.1995-02-07
CT PROSPEED FAMILY (K944013)GE Medical Systems1995-02-07
LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE (K945762)Aaron Medical Industries1995-02-07
THERMORESIN LC II (K942993)GC America, Inc.1995-02-07
RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP (K943879)American Urologicals, Inc.1995-02-07
COLLAGEN INTRACANALICULAR PLUG (K946357)Oasis Medical, Inc.1995-02-07
GABRIEL URETERAL ILLUMINATOR SYSTEM II (K945088)Gabriel Medical, Inc.1995-02-07
CATO FIRST PICC KIT (K945499)Catco Medical, Inc.1995-02-07
CPR SHIELD (K942671)Rondex Products, Inc.1995-02-07
BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP (K945813)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-02-07
LOW TEMPERATURE CAUTERY ELONGATED FINE TIP (K945763)Aaron Medical Industries1995-02-07
LIFESTYLE 55 (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENS (K945981)Permeable Technologies, Inc.1995-02-07
EMERGENCY/ACCIDENT TROLLEY 550 (K946101)Hogan & Hartson1995-02-07
GRAFT THROMBECTOMY INSTRUMENTS (K942457)Intramed Laboratories, Inc.1995-02-07
KLAAS IOL LENSFOLDER (K930628)Bova Intl.1995-02-07
PEDIA PALS, INCORPORATED (K950086)Pedia Pals, Inc.1995-02-07
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Every clearance here is in the API, with alerts when new ones post.