Atlas FDA

1994

5,762 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ISOLATED CAMERA HEAD (K944707)Envision Medical Corp.1994-10-07
GALILEO ARTHROSCOPES (K934707)Galileo Electro-Optics Corp.1994-10-07
VIROTROL TORCH (K942295)Blackhawk Biosystems, Inc.1994-10-07
ENSURE POWDER-FREE LATEX PATIENT EXAMINATION GLOVES (K942643)Basic Intl., Inc.1994-10-07
GUARDIAN SURGEON'S GOWNS (K931562)Atkins Healthcare Services1994-10-07
MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER (K934366)Mitek Surgical Products, Inc.1994-10-07
UNIGRIP (K943502)Unisurge, Inc.1994-10-07
KARL STORZ INSULATED SCISSORS AND RECTAL SNARES (K944530)KARL STORZ Endoscopy-America, Inc.1994-10-07
NORTA (K935630)Beiersdorf, Inc.1994-10-07
URINARY CATECHOLAMINE KIT (K943099)Bioanalytical Systems, Inc.1994-10-07
CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION (K931752)Corin Orthopedic Products1994-10-07
EXAMINATION GLOVES (K942877)Masif Healthcare Products Sdn. Bhd.1994-10-07
SPECIALTY ASSAYED CONTROL-1 (K941737)Helena Laboratories1994-10-07
SILICONE CATHETER REPAIR KITS (K926374)Akcess Medical Products, Inc.1994-10-07
THE HOOK-CURVED CLOSED END/ELECT FIBER LASER DELIV SYS (K944091)Lca, Inc.1994-10-07
BILL EVANS-KLENZ (K944033)Calgon Vestal Div.1994-10-07
1.2 MICRON AIR ELIMINATING FILTER (K942625)The Medi-Dose Group1994-10-07
UPPER EXTERMITY DRAPE KIT (K923960)Medikmark, Inc.1994-10-07
AMPLATZ SUPER STIFF GUIDEWIRE (K944754)Boston Scientific Corp1994-10-07
3M FLUID IRRIGATION SYSTEM (K941388)3M Healthcare1994-10-07
MAUNAL DISPOSABLE DENTAL INSTRUMENTS (K943351)Magnum Instruments, Inc.1994-10-07
CORIN THOMPSON PROSTHESIS, MODIFICATION (K931753)Corin Orthopedic Products1994-10-07
NORELCO CLEAN AIR SYSTEM MODEL CAM665 (K942686)Norelco Consumer Products Co.1994-10-07
CBC-LINE HEMATOLOGY LINEARITY CONTROL (K942822)R&D Systems, Inc.1994-10-07
ACE CEDIA PHENOBARBITAL ASSAY (K942501)Schiapparelli Biosystems, Inc.1994-10-06
COMET CAPNOGRAPH MODULE (K941165)Spacelabs, Inc.1994-10-06
P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT (K935452)Johnson & Johnson Orthopaedics, Inc.1994-10-06
APR ACETABULAR INSERT (K941617)Intermedics Orthopedics1994-10-06
PROTECTAIDE CPR PROTECTION PACK NO. 17701 (K942466)Protectaide, Inc.1994-10-06
VITAFLON PLUS/VASCULON (K941417)Hogan & Hartson1994-10-06
PROTECTAIDE AVIATOR CPR PROTECTION PACK NO. 31000 (K942467)Protectaide, Inc.1994-10-06
THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED (K942551)Medi-Tech, Inc.1994-10-06
HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT (K943334)Jay H. Geller1994-10-05
OPTION SHELL (K942406)Intermedics Orthopedics1994-10-05
OSTEOGRAF/D-100 HYDROXYLAPATITE (K942946)Ceramed Corp.1994-10-05
BREAST SHELL (K944177)O'Donnell, Byrne & Williams1994-10-05
GSI KNOTMAKER (K944536)General Surgical Innovations1994-10-05
MOUTH PROPS (K940785)Worldwide Dental, Inc.1994-10-05
SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE (K931914)Surgimetrics International, Ltd.1994-10-05
URETERAL ILLUMINATOR (K941506)Apple Medical Corp.1994-10-05
ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT (K940235)Wrightmedicaltechnologyinc1994-10-05
AVENT NIPPLE SHIELD (K944117)Avent America, Inc.1994-10-05
HITACHI 914 ANALYZER (K942364)Boehringer Mannheim Corp.1994-10-04
KLS CHIN PLATE SYSTEM (K943348)Patton, Boggs & Blow1994-10-04
MANUAL SURGICAL INST. AND ACC. TO KLS CHIN PLATE SYSTEM (K943345)Patton, Boggs & Blow1994-10-04
AUTONEB ACCESSORY CROSS (AAC) (K944643)Vortran Medical Technology 1, Inc.1994-10-04
ACRYDERM ADVANCED WOUND DRESSING (K943781)Acrymed, Inc.1994-10-04
PATIENT TROLLEY 545 (K943528)Merivaara Instrumentarium Corp.1994-10-04
APR II FEMORAL COMPONENT (VARIOUS) (K942330)Intermedics Orthopedics1994-10-04
ROCHE AMMONIA (VARIOUS) (K942048)Roche Diagnostic Systems, Inc.1994-10-04
MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM (K943346)Patton, Boggs & Blow1994-10-04
PATIENT TROLLEY 540 (K943529)Merivaara Instrumentarium Corp.1994-10-04
POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER (K934132)Porous Media Corp.1994-10-04
THE WUSCOPE SYSTEM (K941319)Achi Corp.1994-10-04
KARL STORZ LARYNGOSCOPE ACCESSORIES (K944295)KARL STORZ Endoscopy-America, Inc.1994-10-04
KOVA LIQUA-TROL (K942853)Hycor Biomedical, Inc.1994-10-04
ULTATHIN FLEXIBLE ENDOSCOPE (K941715)Technology Marketing Group1994-10-04
NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE (K932059)Dantec Medical, Inc.1994-10-04
PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE (K942046)Pharmacia Deltec, Inc.1994-10-04
SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM (K940913)Spine-Tech, Inc.1994-10-04
BRAIN HEART INFUSION AGAR (K944554)Carr-Scarborough Microbiologicals, Inc.1994-10-04
KLS MINI OSTEOSYNTHESIS SYSTEM (K943347)Patton, Boggs & Blow1994-10-04
P.A.T. SYSTEM (K943035)Mathews Assoc., Inc.1994-10-04
HICHEM ENZYME VERIFIER KIT (K943684)Hi Chem, Inc.1994-10-04
MULTI ANALYTE LINEARITY SET (K936245)Teco Diagnostics1994-10-04
SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING (K943925)Quantimetrix Corp.1994-10-04
HP M1722A/B AND M1723A/B CODEMASTER (K944608)Hewlett-Packard Co.1994-10-04
PINNACLE 3 (K926008)Adac Laboratories1994-10-04
OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM (K943054)Osteonics Corp.1994-10-04
LIFE PULSE TESUSCITATION TIMER (K944667)Green Field Medical Sourcing, Inc.1994-10-04
E-Z THERM 3 SECOND THERMOMETER (K932204)North American Technical Services Corp.1994-10-03
DISPOSABLE, PREFORMED FACE MASK (K944157)Meridian Medical Systems, Inc.1994-10-03
ELEGANCE NEONATAL TSH ELISA (K935049)Bioclone Australia Pty , Ltd.1994-10-03
HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD) (K944288)Hemagen Diagnostics, Inc.1994-10-03
SWEMED NEEDLE GUIDE (K925999)Swemed Lab Intl.1994-10-03
S-ROM NOILES CRUCIATE RETAINING KNEE (K936037)Joint Medical Products Corp.1994-10-03
AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTS (K944467)Aesculap, Inc.1994-10-03
FEMININE HEAT WRAP (K924970)Conair Corp.1994-10-03
K-WIRES AND STEINMANN PINS (K941434)Omega Surgical Instruments, Inc.1994-10-03
BEHRING NEPHELOMETER II (K943997)Behring Diagnostics, Inc.1994-10-03
CHIBA STYLE BIOPSY NEEDLE (K944044)Kormed, Inc.1994-10-03
DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM (K941146)Dupont Medical Products1994-10-03
O-R-EZ TIP CLEANER (K944370)O-R-Ez, Inc.1994-10-03
CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING (K940249)Certified Safety Mfg., Inc.1994-10-03
CUSH ISLAND DRESSING (K943424)Cush Medical Products1994-10-03
THE CRADLE (K933964)The Primal Energy Research Foundation1994-10-03
SUNGLASSES (K944281)Sun Glory Optic CO , Ltd.1994-10-03
MSV-2000 VIDEO IMAGING SYSTEM (K942924)Del Medical Systems Corp.1994-10-03
SUNGLASSES (K942011)Shanghai Gopher Arts & Crafts Co., Ltd.1994-10-03
TONKA BOYS SUNGLASSES (K944328)Hasbro Industries, Inc.1994-10-03
BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (K941788)Johnson & Johnson Consumer Products, Inc.1994-10-03
CURADERM ALGINATE HYDROCOLLOID (K943636)Kendall Healthcare Products Co. Div.Of Tyco Health1994-10-03
LIFESHIELD EXTENSION SET (K941214)Abbott Mfg., Inc.1994-10-03
WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE) (K940396)Boston Scientific Scimed, Inc.1994-10-03
PRECISION UV(TM) (VASURFILCON A) (K944722)Pilkington Barnes-Hind, Ltd.1994-10-03
BAND-AID(TM) BRAND ADHESIVE BANDAGE (K940536)Johnson & Johnson Consumer Products, Inc.1994-10-03
AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER (K933916)Ausonics Pty , Ltd.1994-10-03
HYDROTRACK (K935509)Ferno Ille1994-10-03
DISPOSABLE EMERGENCY OBSTETRICAL KIT (K941641)Gam Industries, Inc.1994-10-03
N/T RHEUMATOLOGY CONTROL SL/1, SL/2 (K944375)Behring Diagnostics, Inc.1994-10-03
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Every clearance here is in the API, with alerts when new ones post.