Atlas FDA

1994

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

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RecordFirmDate
HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM (K940957)International Technidyne Corp.1994-10-18
PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. 29777 (K942471)Protectaide, Inc.1994-10-18
GC PATTERN RESIN (K942670)GC America, Inc.1994-10-18
VINYL EXAMINATION GLOVE, POWDER-FREE (K944510)American Gemini, Inc.1994-10-18
PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. B3069 (K942476)Protectaide, Inc.1994-10-18
LOCALMED INFUSION CATHETER (K935349)Localmed, Inc.1994-10-18
AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER (K926334)Orthomet, Inc.1994-10-18
CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER (K923946)Hudson Respiratory Care, Inc.1994-10-18
MICRO OSTEOSYNTHESIS SYSTEM (1.0) (K944561)KLS-Martin L.P.1994-10-18
FASGUIDE CATHETER (K935597)Target Therapeutics1994-10-18
PROTECTAIDE PERSONAL PROTECTION PACK NO. 26123 (K942472)Protectaide, Inc.1994-10-18
POWERCHARGER (K934016)Zoll Medical Corp1994-10-18
KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM) (K944565)KLS-Martin L.P.1994-10-18
PROTECTAIDE PERSONAL PROTECTION PACK NO. 12351 (K942475)Protectaide, Inc.1994-10-18
MARQUETTE ADULT/NEONATAL WRAP SENSOR (K943817)Marquette Electronics, Inc.1994-10-18
PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000 (K942474)Protectaide, Inc.1994-10-18
NASCOR IGLOO (K935126)Nascor Pty. , Ltd.1994-10-18
HYSTEROMED 100 (K930912)Northgate Technologies, Inc.1994-10-17
AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT (K943456)Datex Division Instrumentarium Corp.1994-10-17
ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET) (K943586)Biomet, Inc.1994-10-17
BEDSIDE BUTLER (K944345)Trac Medical, Inc.1994-10-17
2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE (K944849)Conmed Andover Medical, Inc.1994-10-17
CAPNOCHECK (K941982)Bci, Inc.1994-10-17
DURA-Y OXYGEN TRANSDUCER, EAR CLIP (K944760)Nellcor, Inc.1994-10-17
MALIBU BATHING SYSTEM (K925195)Medi-Man Rehabilitation Products, Inc.1994-10-17
LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI) (K944574)Lumex, Inc.1994-10-17
FRESENIUS DIALYSATE ACID CONCENTRATE (K922088)Fresenius USA, Inc.1994-10-17
MEDICAM XENON LIGHT SOURCE (K943342)M.P. Video, Inc.1994-10-17
PAM CARDIAC MONITOR (K934684)Technology Transfer, Inc.1994-10-17
PRESS-MATE BP8800MS AUTOMATIC NON-INVASIVE BLOOD PRESSURE SYSTEM (K942871)Colin Medical Instruments Corp.1994-10-17
AMSCO SQ240 SURGICAL LIGHT (K943288)American Sterilizer Co.1994-10-17
PRESERVATION UNICOMPARTMENTAL KNEE (K941606)Depuy, Inc.1994-10-14
B-D GUARDIAN NESTABLE SHARPS COLLECTORS (K943575)Bd Becton Dickinson Vacutainer Systems Preanalytic1994-10-14
RIGID TELESCOPES (K943904)Karl Storz Endoskop GmbH1994-10-14
MRT-150A (K943021)Toshiba America Mri, Inc.1994-10-14
MICRO THERAPEUTICS INFUSION CATHETER (K940634)Micro Therapeutics, Inc.1994-10-14
ARTERIAL EMBOLIZATION DEVICE (KRD) (K940982)Cook, Inc.1994-10-14
AML TRILOCK REPLACEMENT LINER SYSTEM (K942966)Depuy, Inc.1994-10-14
MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE (K944837)Medical Device Technologies, Inc.1994-10-14
HEAT AND MOISTURE EXCHANGER FILTER (HME) (K943915)Medicomp, Inc.1994-10-14
ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM (K935593)Biodynamic Technologies, Inc.1994-10-14
MUMPS STAT (K925209)Biowhittaker Molecular Applications, Inc.1994-10-14
CUFF-CATH (K935090)Ohmeda Medical1994-10-14
AXIOM TOTAL KNEE SYSTEM (K932677)Orthomet, Inc.1994-10-14
ADAM SHELL THERMOCOUPLE ASSEMBLY (K944175)Pro-Tech Services, Inc.1994-10-14
CANNULATED BONE SCREW (K943474)Cohort Medical Products Group, Inc.1994-10-14
CHIN UP (K943837)Edward Carden1994-10-14
CARBON LIGHTS HAND SURGERY TABLE (K944779)Allen Medical Systems, Inc.1994-10-14
BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER (K936232)Boston Scientific Corp1994-10-14
SOLUTION BOWED FEMORAL HIP PROTSTHESIS (K933942)Depuy, Inc.1994-10-14
ORTHOMET LHMC FEMORAL STEM (K931678)Orthomet, Inc.1994-10-14
KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR (K944296)KARL STORZ Endoscopy-America, Inc.1994-10-14
ORTHOMET ACETABULAR CUP SYSTEM (K931333)Orthomet, Inc.1994-10-14
RESCUE BREATHER (K940927)O-Two Systems Intl., Inc.1994-10-14
AML TRI-LOCK REPLACEMENT LINER SYSTEM (K943302)Depuy, Inc.1994-10-14
PROXIMAL HUMERAL REPLACEMENT SYSTEM (K925613)Biomet, Inc.1994-10-14
LORAD TRANSPO (K934868)Lorad Corp.1994-10-14
SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR (K942731)Shimadzu Corp.1994-10-13
SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER (K943777)Scimed Life Systems, Inc.1994-10-13
HAND-HELD NEBULIZER (K940257)Nutec, Inc.1994-10-13
QUANTASE PHENYLALANINE ASSAY (K922547)Porton Cambridge , Ltd.1994-10-13
POWDERED DISPOSABLE LATEX EXAM GLOVES/ANNEXURES (K942149)Ti-Mate Prophylactic Devices , Ltd.1994-10-13
BURDICK PRO2 OXIMETER (K941351)Burdick Corp.1994-10-13
UNIHEART (K943600)Vortran Medical Technology 1, Inc.1994-10-13
7 FRENCH LARGE LUMEN TRIGUIDE-PLUS (K943783)Scimed Life Systems, Inc.1994-10-13
GLASSMAN SILICONE CATHETER (K934895)Axiom Medical, Inc.1994-10-13
GALILEO ENDOSCOPES (K934649)Galileo Electro-Optics Corp.1994-10-13
APHLELISA KIT (K933588)Louisville Apl Diagnostics, Inc.1994-10-13
3301 PULSE OXIMETER (K943404)Bci Intl., Inc.1994-10-13
INJECT-SNARE (K942110)Endovations1994-10-13
LSVP INTERNATIONAL BIOPSY FORCEPS (K944770)Lsvp Intl., Inc.1994-10-13
AGGRO/LINK VW COFACTOR SOFTWARE (K940792)Chrono-Log Corp.1994-10-13
CATCO UROLOGICAL CATHETER (K944782)Catco Medical, Inc.1994-10-13
PATIENT SUPPORT SYSTEM (K940872)Arylift, Inc.1994-10-13
OCU-FLEX-38 (POLYMACON) (K941998)Ocu-Ease Optical Products, Inc.1994-10-13
PHACO NEEDLES AND TIPS (K943672)Microsurgical Technology, Inc.1994-10-13
COMFIT (STERILE) (K944141)Wembley Rubber Products (M) Sdn Bhd1994-10-13
PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM (K931423)Orthomed1994-10-13
PROGRAM 3-CH SERIES HEAR AIDS W/DT-1 DESKTOP PROGRAM (K944077)Argosy Electronics1994-10-12
NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS (K943665)Olympus America, Inc.1994-10-11
EURO TECH DIAMOND CHIROPRACTIC TABLE (K943972)Progressive Electrical Therapeutics1994-10-11
OXYGEN MOUTHGUARD (K944049)Endovations, Inc.1994-10-11
COHORT BONE BRUSH (K942108)Advanced Med/Surg, Inc.1994-10-11
RYDER CONTACT LENS CASE (K943921)Clinical Research Assoc.1994-10-11
ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION (K935295)Howmedica Corp.1994-10-11
ENDOSCOPIC PLANTAR FASCIA KIT (K940847)Citation Medical Corp.1994-10-11
VIDEO OTOSCOPE (K943731)Cuda Products Co.1994-10-11
TINA-QUANT HEMOGLOBIN A1C (K934070)Boehringer Mannheim Corp.1994-10-11
PHILIPS TOMOSCAN SR 4000 (K936272)Philips Medical Systems North America, Inc.1994-10-11
LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT (K944640)Gabris Surgical Corp.1994-10-11
CKS POROUS COATED FEMORAL COMPONENT (K933935)Techmedica, Inc.1994-10-11
PHACO TIPS FOR PHACO FRAGMENTATION MACHINES (K943379)Oasis Medical, Inc.1994-10-11
ELECTROSURGICAL UNIT MODEL 26-0335 (K944775)Cameron-Miller, Inc.1994-10-11
PEGASUS (K935009)Advanced Technology Laboratories, Inc.1994-10-11
GENESIS 2000 (K944206)Ion Laser Technology1994-10-11
INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P. (K943253)Innerdyne Medical, Inc.1994-10-11
GENESIS 2000 (K944317)Ion Laser Technology1994-10-11
TYMPANOSTOMY TUBE (K943325)Grace Medical, Inc.1994-10-11
3M FLUID CONTROL SYSTEM 8300 CASSETTE LOAD (K941718)3M Medical Products Group1994-10-07
NUFFIELD TOTAL KNEE (K931960)Turnkey Intergration USA, Inc.1994-10-07
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Every clearance here is in the API, with alerts when new ones post.