Atlas FDA

1994

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

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RecordFirmDate
B-D GUARDIAN ONE PIECE SHARPS COLLECTORS (K943139)Med-Safe Systems, Inc.1994-11-28
NORELCO CLEAN AIR SYSTEM CAS950 (K945161)Hogan & Hartson1994-11-28
BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550 (K942683)Bionaire Corp.1994-11-28
STRYKER SURGICAL INSTRUMENTS AND ACCESSORIES (K943323)Stryker Corp.1994-11-28
MAG-1 SPECTACLE FRAME (K945342)Criss Optical Mfg. Co., Inc.1994-11-28
BGM CELL CULTURE (K943886)Neogenex1994-11-28
RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE (K943926)Philips Medical Systems (Cleveland), Inc.1994-11-28
SURGICAL MICROSCOPE DRAPE (K944198)Hydro-Med Products, Inc.1994-11-27
ECG ELECTRODE (K944655)Conmed Andover Medical, Inc.1994-11-22
TRIGEL MULTIFUNCTION ELECTRODE (K934505)Physiometrix, Inc.1994-11-22
MENISCAL SUTURE INSTRUMENTARIUM (K940287)Richard Wolf Medical Instruments Corp.1994-11-22
GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE) (K940534)Philips Medical Systems, Inc.1994-11-22
VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS (K942211)Sensor Medics Corp.1994-11-22
OKTAS INTRA-ORAL DENTAL CAMERA (K944256)Oktas1994-11-22
QUANTITATE URIC ACID VERIFIER SET (K944453)Beckman Instruments, Inc.1994-11-22
OPTIMA DELIVERY BED (MODELS 33901, 33903, 33902, 33905) (K944929)Merivaara Instrumentarium Corp.1994-11-22
CREATININE QVET (K943005)Prisma Systems1994-11-22
TRIGLYCERODES QVET (K942998)Prisma Systems1994-11-22
AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT (K941550)Chiron Vision Corp.1994-11-22
1710 MONITORING ECG ELECTRODE (K944726)Conmed Andover Medical, Inc.1994-11-22
AXIOM, SUNFAST (K944915)Axiom Ent. Co., Ltd.1994-11-22
KARL STORZ INSULATED SCISSORS (K944298)KARL STORZ Endoscopy-America, Inc.1994-11-22
MAKROLON 2405 GOGGLES (LIGHT AND DARK) (K945346)Universal Massage & Tanning, Inc.1994-11-22
VIDENT IMPAC IMPLANT ACCESSORIES (K923395)Vident1994-11-22
HEARING AID (ACCESSORY) (K944009)Phoenix Management, Inc.1994-11-22
FOCOMETER (K944402)Lacrimedics, Inc.1994-11-22
ADVANCED MAGMAG AC/BATTERY BREAST PUMP (K935249)Pigeon Corp.1994-11-22
CEMAX SCANLINK V (K943357)Cemax, Inc.1994-11-22
BLOCKING TRAY (K944315)Medtec, Inc.1994-11-22
SURGICAL INSTRUMENT TRAY (K944025)Riley Medical, Inc.1994-11-22
'LIL MAC ACCESSORY CLAMP(TM) (K945415)D.L. Nelson and Assoc., Inc.1994-11-22
MICROMED PARTIAL REGULAR AND PARTIAL OFFSET (K945104)Micromed Development Corp.1994-11-22
MCI OPTONIX CASSETTE OKAMOTO CASSETE (K945039)Mci Optonix, Inc.1994-11-22
GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS (K942544)Medi-Globe Corp.1994-11-22
MICROMED TOTAL REGULAR AND PARTIAL OFFSET (K945106)Micromed Development Corp.1994-11-22
ARISTAR EYEWEAR, ESPRIT EYEWEAR (K945123)Aristar Inc. U.S.A.1994-11-22
EDI-BUR MICRODRILL SYSTEMS (K945438)Micromed Development Corp.1994-11-22
DADE INNOVIN II (K935702)Baxter Diagnostics, Inc.1994-11-22
UNBREAKABLE LENS (K941437)Nam Hing Plastic Factory , Ltd.1994-11-22
INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER (K940671)Interspec, Inc.1994-11-22
IMAGING WORKBENCH (K943383)Brit Systems, Inc.1994-11-22
STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY (K933414)Baxter Diagnostics, Inc.1994-11-22
CLARUS ENDOSCOPIC NEUROLOGICAL TISSUE ELEVATOR (K942413)Clarus Medical Systems, Inc.1994-11-22
EPIVIEW (K940895)Convatec, A Bristol-Myers Squibb Co.1994-11-22
DERMAGRAN HYDROPHILIC OINTMENT (K944491)Derma Sciences, Inc.1994-11-22
KEELER MULTILASE 3000 (K942180)Keeler Instruments, Inc.1994-11-22
BREAST LESION LOCALIZATION NEEDLE (K945124)Promex, Inc.1994-11-22
BILIRUBIN (DIRECT) QVET (K942949)Prisma Systems1994-11-22
DANESHVAR'S DEVICE (K935494)Y. Daneshvar1994-11-22
GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER (K933360)Miles Inc., Dental Products1994-11-22
ALT QVET (K944080)Prisma Systems1994-11-22
ARISTAR EYEWEAR, ESPRIT EYEWEAR (K945122)Aristar Inc. U.S.A.1994-11-22
WANG BRONCHIAL NEEDLE BRUSH (K944650)Mill-Rose Laboratory1994-11-22
RED DRAGON CORPORATION (K945249)J C Intl., Inc.1994-11-22
LAPAROSCOPIC SURGICAL INSTRUMENTS FOR GENERAL USE (K945369)Advanced Surgical, Inc.1994-11-22
SPECTACLE FRAMES OR EYEGLASS FRAMES (K945340)Mi Mun Corp.1994-11-22
ELECTRIC SURGICAL DRILL (K940016)Alamo City Dental Supply Co.1994-11-22
BRIGHTEN (K945036)New Daley Intl. Trading Co.1994-11-22
DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA (K935307)Baxter Diagnostics, Inc.1994-11-22
SPECTACLE FRAME (K945323)M.Y. Vision Corp.1994-11-22
PIONEER LABORATORIES BONE SCREW (K940690)Pioneer Surgical Technology1994-11-22
SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR (K944312)Shelin International Ent., Inc.1994-11-22
POLY-WIRE PISTON (K945107)Micromed Development Corp.1994-11-22
SCIMED CHOICE(TM) PTCA GUIDE WIRE (K943192)Scimed Life Systems, Inc.1994-11-22
STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY (K934003)Baxter Diagnostics, Inc.1994-11-22
AD/V IMAGEPLEX(TM) (K943158)Adaptive Video, Inc.1994-11-22
TOMEY EM-1000 SPECULAR MICROSCOPE (K944910)Tomey Corporation USA1994-11-22
SYNERGY II (K942445)Synectics Medical, Inc.1994-11-22
KARL STORZ INSULATED CANNULAE, SUCTION TUBES (K944797)KARL STORZ Endoscopy-America, Inc.1994-11-22
GIP/MED-GLOBE STONE EXTRACTOR BASKETS (K942005)Medi-Globe Corp.1994-11-22
POLY PISTON (K945108)Micromed Development Corp.1994-11-22
ARTHROSCOPE (K943628)Electro Fiberoptics Corp.1994-11-22
NON-PRESCRIPTION SUNGLASSES (K944996)La Kinglong Intl., Inc.1994-11-22
KERATRON CORNEAL TOPOGRAPHER (K944616)Alliance Medical Marketinig1994-11-22
FRAME, SPECTACLE (K945450)Kookje Apis Industrial Co.1994-11-22
CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS (K944088)Beckman Instruments, Inc.1994-11-21
DANEKSCOPE OPTI-PROBE (K943676)Danek Medical, Inc.1994-11-21
SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302 (K941872)Helena Laboratories1994-11-21
MICRO MPM (K940375)Micro Direct, Inc.1994-11-21
CX(TM) BENZODIAZEPINE(BENZ) REAGENT FOR SYCHRON CX SYS (K944076)Beckman Instruments, Inc.1994-11-21
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM (K944096)Immuno Concepts, Inc.1994-11-21
STERILE .9% SODIUM CHLORIDE FOR IRRATION (K943832)Orion Life Systems, Inc.1994-11-21
DIASTAT ENA SINGLE WELL SCREEN KIT (K944505)Shield Diagnostics, Ltd.1994-11-21
DAKO MOUSE ANTI-HUMAN T-CELL (K924804)Dako Corp.1994-11-21
MONOCLONAL MOUSE ANTI-HUMAN B-CELL (K943284)Dako Corp.1994-11-21
9100 MUTIGAS MONITOR (K941971)Bci Intl., Inc.1994-11-21
PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER (K943831)Orion Life Systems, Inc.1994-11-21
IMPAC TORQUE WRENCH (K940998)Vident1994-11-21
PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER (K943836)Orion Life Systems, Inc.1994-11-21
CALIBRATORS (K944701)Diagnostic Reagents, Inc.1994-11-21
STERILE WATER FOR IRRIGATION (K943828)Orion Life Systems, Inc.1994-11-21
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25 (K944253)Dako Corp.1994-11-21
VIDENT IMPAC INFINITE POSITION ABUTMENT (K941247)Vident1994-11-21
INSIGHT ELECTRONIC ALIGNMENT INDICATOR (K940812)Andronic Devices, Ltd.1994-11-21
ACCESS CK-MB REAGENTS (K945083)Bio-Rad Laboratories, Inc.1994-11-21
PRE-FILLED SYSRINGE W/STERILE WATER (K943829)Orion Life Systems, Inc.1994-11-21
CREATINE KINASE MB DETERMINATION (UV) (K942958)Biochemical Trade, Inc.1994-11-21
PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION (K943830)Orion Life Systems, Inc.1994-11-21
STERILE .9% SODIUM CHLORIDE SOLUTION (K943834)Orion Life Systems, Inc.1994-11-21
OTOVIEW TELESCOPIC OTOSCOPES (K943721)Smith & Nephew, Inc.1994-11-18
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Every clearance here is in the API, with alerts when new ones post.